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                CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA)

                        About CDER Small Business and Industry Assistance (SBIA)
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  					Online Training Repository
	
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    PrintThe table below lists SBIA multimedia training resources, including conference/webinar presentations and recordings, online courses, newsletters and podcasts.  Explore the SBIA recordings on YouTube to browse by most popular videos and see upcoming events for a list of future live events.

*You can now find Spanish captions for selected training modules as the FDA expands language accessibility to audiences in the Latin America Region and the U.S. Click “Subtítulos en Español” to the right of the list below to use this feature. You can also find this training on our SBIA Spanish Captions YouTube playlist.*

*Ahora se tienen subtítulos en español para módulos de capacitación seleccionados ya que la FDA está ampliando la accesibilidad en cuanto al idioma para audiencias en la región de América Latina y los Estados Unidos. Haga clic en “Subtítulos en Español” a la derecha de la siguiente lista para utilizar esta modalidad. También puede encontrar esta capacitación en nuestra lista de reproducción en español en YouTube.*


SBIA Recordings on YouTube


Upcoming SBIA Events


Use filters and search box to find resources

Advanced search (combine topic and search terms)

Type CDERLearn CourseConference/WorkshopSBIA ChroniclesSBIA Chronicles PodcastSymposiumWebinar


Topic Analytical ValidationANDABioavailabilityBioequivalenceBiologicsBiomarkersBiosimilarsBLAChemistry Manufacturing and Controls (CMC)Clinical Trials and ResearchClinicalTrials.govComplex Generic DrugCompoundingContinuous ManufacturingCurrent Good Manufacturing Practice (CGMP)Data ManagementData StandardsDelivery SystemDigital Health TechnologiesDistributorDrug DevelopmentDrug InteractionDrug Master FilesDrug QualityDrug SafetyDrug Supply ChainDSCSAEmerging TechnologyFDA Form 483FDA Meetings/CommunicationsGeneric Drug DevelopmentImport/ExportINDInspectionsIntegrated Safety AnalysesInternationalInvestigationsLabelingLipidLiposomeManufacturingMarketingMeetingsNanomaterialsNDANew Drug DevelopmentNoncirrhotic NASHNon-ClinicalNoninvasive testsOTC Drug RegulationPost ApprovalProduct Specific GuidancesQuality AssessmentsReal World EvidenceRecallsRegistration and ListingRegulatory AssessmentRegulatory ScienceRegulatory SubmissionsResourcesSafetySupply ChainSurrogate EndpointsTherapeutic ProteinUnique Serial NumbersUser FeesWholesaler

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Summary
			Type
			Issued/Updated
			Topic
			Subtítulos en EspañolExpanding Generic Drug Access Through International Engagements
			Webinar
			2/28/2024
			ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International
			NoIntegrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes
			Webinar
			3/7/2024
			Clinical Trials and Research, New Drug Development, Integrated Safety Analyses
			NoJoint US FDA – Health Canada ICH Public Meeting
			Webinar
			2/22/2024
			International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management
			NoA Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs
			Webinar
			1/18/2024
			Generic Drug Development, Bioequivalence, ANDA, Meetings
			NoeCTD (7/28) Generic Drugs Forum 201
			Webinar
			4/4/2017
			ANDA, Generic Drug Development, Regulatory Submissions
			Disponible/AvailableIntroduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017
			Webinar
			4/4/2017
			ANDA, Generic Drug Development, Regulatory Submissions
			Disponible/AvailableFDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017
			Webinar
			4/4/2017
			ANDA, Bioequivalence, Generic Drug Development, Regulatory Assessment
			Disponible/AvailableManufacturing Process and Controls (25/28) Generic Drugs Forum 2017
			Webinar
			4/4/2017
			ANDA, Chemistry Manufacturing and Contgrols (CMC), Drug Quality, Generic Drug Development
			Disponible/AvailableDrug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019
			Webinar
			4/3/2019
			ANDA, Drug Master Files, Generic Drug Development, Regulatory Assessment, Regulatory Submissions
			Disponible/AvailableOrange Book - Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019
			Webinar
			4/3/2019
			ANDA;Generic Drug Development; New Drug Development; Orange Book
			Disponible/AvailableProduct Specific Guidances (PSGs) Generic Drugs Forum 2020
			Webinar
			4/15/2020
			ANDA; Complex Generic Drug; Generic Drug Development; Product Specific Guidances
			Disponible/AvailablePost-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
			Webinar
			6/30/2020
			Manufacturing; Regulatory Submissions
			Disponible/AvailableFDA Drug Manufacturing Inspections - REdI 2020
			Webinar
			6/30/2020
			Manufacturing; Inspections; Regulatory Submissions
			Disponible/AvailableANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues
			Webinar
			4/28/2021
			ANDA; Generic Drug Development; Quality Assessments
			Disponible/AvailableA Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium
			Symposium
			2/13/2024
			New Drug Development, Clinical Trials and Research, ANDA, Bioequivalence, BLA, Digital Health Technologies, International, Regulatory Assessment, Inspections
			NoNavigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources
			Webinar
			12/12/2023
			IND, Labeling, Drug Interaction, Therapeutic Protein
			NoFDA Clinical Investigator Training Course (CITC) 2023
			Conference
			12/6/2023
			IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies
			NoToward Global IDMP Implementation: A Focus on Global Use Cases
			Webinar
			11/28/2023
			Regulatory Submissions, Data Standards
			NoCommon Issues with SEND Data Submitted for Safety Pharmacology Studies
			Webinar
			11/16/2023
			Regulatory Submissions, Data Standards
			NoImplementing DSCSA: Stabilization Period and Expectations
			Webinar
			11/3/2023
			DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers
			NoPharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing
			Symposium
			10/31/2023
			Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology
			NoBsUFA III Regulatory Science Pilot Program
			Webinar
			10/16/2023
			Biomarkers, Regulatory Science, BLA, Biologics
			No2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
			Symposium
			10/11/2023
			Generic Drug Development, New Drug Development, IND, NDA, BLA, ANDA, Nanomaterials, Non-Clinical, Quality Assessment, Continuous Manufacturing, Regulatory Science, Delivery System, Lipid, Liposome
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023
			Conference/Workshop
			9/28/2023
			Registration and Listing, Import/Export
			NoUse of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials
			Conference/Workshop
			9/18/2023
			Clinical Trials and Research, New Drug Development, Biomarkers, Surrogate Endpoints, Noninvasive tests, Noncirrhotic NASH
			NoAdvancing Generic Drug Development: Translating Science to Approval 2023
			Conference
			9/13/2023
			ANDA, Generic Drug Development, Complex Generic Drug, Product Specific Guidances, Regulatory Assessment
			NoUnderstanding FDA Inspections and Data
			Webinar
			9/6/2023
			Inspections, International, Current Good Manufacturing Practice (CGMP)
			NoOTC Monograph Reform: OMOR Format and Content & Electronic Submissions
			Webinar
			8/22/2023
			OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development
			NoUsing Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products
			SBIA Chronicles Podcast
			8/17/2023
			Clinical Trials and Research
			NoUsing Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products
			SBIA Chronicles
			8/17/2023
			Clinical Trials and Research
			NoClinicalTrials.gov – a Three-Part Series
			Webinar
			8/9/2023
			ClinicalTrials.gov, Clinical Trials and Research
			NoInsights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
			SBIA Chronicles
			7/11/2023
			Generic Drug Development
			NoInsights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products
			SBIA Chronicles Podcast
			7/11/2023
			Generic Drug Development
			NoDecentralized Clinical Trials (DCT) Draft Guidance
			Webinar
			6/20/2023
			Clinical Trials and Research, IND, New Drug Development
			NoOverview: Clinical Pharmacology Considerations for Food Effect Studies
			Webinar
			6/15/2023
			Drug Development, Regulatory Submissions
			NoRegulatory Education for Industry (REdI) Annual Conference 2023
			Conference
			6/5/2023
			BLA, Chemistry Manufacturing and Controls (CMC), Digital Health Technologies, Drug Development, FDA Meetings/Communications, IND, NDA, New Drug Development, Real World Evidence, and Regulatory Submissions
			NoAn Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)
			Webinar
			5/24/2023
			Drug Quality, Regulatory Submissions, and Quality Assessments
			NoOTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration
			Webinar
			5/16/2023
			OTC Drug Regulation, User Fees
			NoA Deep Dive: GDUFA III Scientific Meetings
			Webinar
			5/15/2023
			ANDA, Generic Drug Development, FDA Meetings/Communications
			NoNavigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
			Webinar
			5/2/2023
			Generic Drug Development, International
			NoElectronic Systems, Electronic Records, and Electronic Signatures Webinar
			Webinar
			4/25/2023
			New Drug Development, Clinical Trials and Research, IND
			NoFDA’s Dosage and Administration Section of Labeling Draft Guidance
			Webinar
			4/19/2023
			Labeling
			NoThe Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
			SBIA Chronicles Podcast
			4/10/2023
			Biosimilars
			NoThe Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development
			SBIA Chronicles
			4/10/2023
			Biosimilars
			NoGeneric Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF
			Conference
			4/7/2023
			Generic Drug Development
			NoA Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence
			Webinar
			3/14/2023
			Bioequivalence, Generic Drug Development, Drug Development
			NoJoint US FDA – Health Canada ICH Public Meeting
			Webinar
			2/24/2023
			Clinical Trials and Research, International, New Drug Development
			NoOverview: Clinical Pharmacology Considerations for Neonatal Studies
			Webinar
			2/15/2023
			Clinical Trials and Research, IND, NDA, BLA, New Drug Development
			NoFDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
			SBIA Chronicles
			2/6/2023
			Drug Quality
			NoFDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds
			SBIA Chronicles Podcast
			2/6/2023
			Drug Quality
			NoOverview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use
			Webinar
			2/1/2023
			OTC Drug Regulation
			NoFDA’s Labeling Resources for Human Prescription Drugs
			Webinar
			1/26/2023
			Labeling
			NoReporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards
			Webinar
			1/13/2023
			Regulatory Submissions, Safety
			NoWhat to Expect after an Inspection: 483s, Responses and Beyond
			Webinar
			12/14/2022
			Compliance, Compounding, Inspections, FDA Form 483
			NoFDA Clinical Investigator Training Course (CITC) 2022
			Conference
			12/7/2022
			IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies
			NoDrug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions
			Conference/Workshop
			11/30/2022
			ANDA, Drug Master Files, Generic Drug Development, Regulatory Submissions, Quality Assessments
			NoProposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements
			Webinar
			11/17/2022
			Registration and Listing
			NoAn In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations
			Webinar
			10/26/2022
			Drug Development, New Drug Development, Bioequivalence, Bioavailability, IND, NDA
			NoFDA NanoDay Symposium 2022
			Symposium
			10/11/2022
			Generic Drug Development, New Drug Development, IND, NDA, Chemistry Manufacturing and Controls (CMC), Nanomaterials, Non-Clinical, ANDA
			NoStudy Data Standards Update for CBER: Your Guide to a Successful Submission
			Webinar
			10/6/2022
			Data Standards, Regulatory Submissions
			NoThe FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
			SBIA Chronicles
			9/29/2022
			Compounding
			NoThe FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities
			SBIA Chronicles Podcast
			9/29/2022
			Compounding
			NoAdvancing Generic Drug Development: Translating Science to Approval
			Conference
			9/20/2022
			Generic Drug Development, Drug Quality, Regulatory Submissions
			NoReporting Drug Amount Under Section 510(j)(3) of the FD&C Act
			Webinar
			9/8/2022
			Registration and Listing
			NoRegulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines
			Conference
			8/16/2022
			Drug Development, Drug Quality, Generic Drug Development, New Drug Development, IND, International, Post Approval
			NoBest Practices for Topical Generic Product Development and ANDA Submission
			Webinar
			8/11/2022
			Generic Drug Development
			NoDecoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use
			Webinar
			8/10/2022
			Generic Drug Development
			NoOffice of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites
			Conference
			7/19/2022
			Drug Development, Inspections, New Drug Development, IND
			NoAn FDA Self-Audit of Continuous Manufacturing for Drug Products
			SBIA Chronicles
			6/28/2022
			Drug Quality
			NoAn FDA Self-Audit of Continuous Manufacturing for Drug Products
			SBIA Chronicles Podcast
			6/28/2022
			Drug Quality
			NoRegulatory Education for Industry (REdI) Annual Conference 2022
			Conference
			6/6/2022
			Biosimilars, Drug Development, DSCSA, FDA Meetings/Communications, Inspections, NDA, New Drug Development, Regulatory Submissions, Resources, Safety
			NoQuality Management Maturity Workshop
			Webinar
			5/24/2022
			Drug Quality
			NoUS-Canada Regional ICH Consultation
			Webinar
			5/11/2022
			Clinical Trials and Research; International; New Drug Development
			NoFDA Workshop on the Role of Phytosterols in PNALD/IFALD
			Webinar
			5/6/2022
			Drug Development
			NoGeneric Drugs Forum 2022: The Current State of Generic Drugs
			Conference/Workshop
			4/26/2022
			Generic Drug Development
			NoThe Key Elements of Being “Recall-Ready”
			CDER SBIA Chronicles
			4/20/2022
			Recalls
			NoThe Key Elements of Being "Recall-Ready"
			CDER SBIA Chronicles Podcast
			4/20/2022
			Recalls
			NoProposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers
			Webinar
			4/13/2022
			DSCSA
			NoFDA Inspections of Outsourcing Facilities
			Webinar
			4/6/2022
			Compounding, Inspections
			NoImmunogenicity Information in Labeling
			Webinar
			4/5/2022
			Drug Development, Labeling
			NoOTC Monograph Reform: Overview of Draft Guidance for Formal Meetings
			Webinar
			3/29/2022
			OTC Drug Regulation, Clinical Trials and Research, Regulatory Submissions, FDA Meetings/Communications
			NoFDA-EMA Parallel Scientific Advice (PSA) Program
			Webinar
			3/16/2022
			New Drug Development, Drug Development, International, Regulatory Submissions
			NoBioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA
			Webinar
			2/24/2022
			Drug Development, Generic Drug Development
			NoCDER BIMO GCP Compliance and Enforcement
			Webinar
			2/16/2022
			Clinical Trials and Research, Inspections, New Drug Development
			NoDigital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance
			Webinar
			2/10/2022
			New Drug Development, Clinical Trials and Research, IND
			NoToward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics
			Webinar
			1/27/2022
			New Drug Development, Labeling, Post Approval, Clinical Trials and Research
			NoOTC Monograph Reform: Deemed Final Orders
			Webinar
			12/15/2021
			OTC Drug Regulation
			NoOTC Monograph Reform: OTC Sunscreen Drugs
			Webinar
			12/15/2021
			OTC Drug Regulation
			NoClinical Investigator Training Course (CITC) Update
			Webinar
			12/7/2021
			Clinical Trials and Research, New Drug Development
			NoPharmaceutical Quality Symposium 2021: Innovations in a Changing World
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 4
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 5
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 6
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 7
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoPharmaceutical Quality Symposium 2021 Part 8
			Conference/Workshop
			10/26/2021
			Drug Quality
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address
			Conference/Workshop
			10/13/2021
			Registration and Listing
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2
			Conference/Workshop
			10/13/2021
			Registration and Listing
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3
			Conference/Workshop
			10/13/2021
			Registration and Listing
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks
			Conference/Workshop
			10/13/2021
			Registration and Listing
			NoElectronic Drug Registration and Listing (eDRLS) Using CDER Direct
			Conference/Workshop
			10/13/2021
			Registration and Listing
			NoEnhanced Drug Distribution Security in 2023 Under the DSCSA
			Webinar
			10/5/2021
			DSCSA
			NoInvestigator Responsibilities — Safety Reporting for Investigational Drugs and Device
			Webinar
			9/29/2021
			IND, Safety
			NoAdvancing Generic Drug Development: Translating Science to Approval
			Conference/Workshop
			9/21/2021
			Generic Drug Development
			NoAdvancing Generic Drug Development: Translating Science to Approval Keynote Address
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoCOVID-19 Impact on Generic Drug Regulation and Evaluation + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoConsiderations in Assessing Generic Drug Products of Oral Dosage Forms + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoComplex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoComplex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoAdvancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoCutting Edge Science in Complex Generics + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoComplex Generics_Nasal and Inhalation Products + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoComplex Generics_Topical Products, Part 1 + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoComplex Generics_Topical Products, Part 2 + QA
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoAdvancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks
			Conference/Workshop
			9/15/2021
			Generic Drug Development
			NoThe ABCs of Product Specific Guidances
			CDER SBIA Chronicles
			9/2/2021
			Generic Drug Development
			NoThe ABCs of Product Specific Guidances
			CDER SBIA Chronicles Podcast
			9/2/2021
			Generic Drug Development
			NoPromotional Submissions in eCTD Format – Grouped Submissions
			Webinar
			8/31/2021
			Regulatory Submissions
			NoManufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency
			Webinar
			8/25/2021
			Inspections; Drug Quality; DSCSA
			NoRegulatory Education for Industry (REdI) Annual Conference 2021
			Conference/Workshop
			7/19/2021
			New Drug Development
			No2021 REdI Conference Keynote Address by Janet Woodcock, MD
			Conference/Workshop
			7/19/2021
			New Drug Development
			No2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoOND Reorganization and the New Drugs Regulatory Program Modernization
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoANDA Efforts Related to COVID-19
			Conference/Workshop
			7/19/2021
			Generic Drug Development
			NoResource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoCDER NextGen Portal
			Conference/Workshop
			7/19/2021
			Regulatory Submissions
			NoElectronic Common Technical Document (eCTD)
			Conference/Workshop
			7/19/2021
			Regulatory Submissions
			NoProduct Quality Consideration for Emergency Use Authorizations (EUAs)
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoStrategies to Address Potential Medication Errors for EUA Products for COVID-19
			Conference/Workshop
			7/19/2021
			New Drug Development; Safety
			NoClinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoCDER’s Role in Public Health Emergency Response and Medical Countermeasure Development
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoWhere Do We Go from Here? How the Ombudsman Can Help
			Conference/Workshop
			7/19/2021
			FDA Meetings/Communications
			NoCommunication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO
			Conference/Workshop
			7/19/2021
			FDA Meetings/Communications
			NoCommunications in a Global Pandemic
			Conference/Workshop
			7/19/2021
			FDA Meetings/Communications
			NoRegulatory Policy: Role in Guiding Decision Making in CDER
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoRole of the Product Jurisdiction Team in the Medical Product Development Process
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoFDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency
			Conference/Workshop
			7/19/2021
			New Drug Development; Clinical Trials and Research
			NoOSI’s Role in the Drug Development Process and Impact of COVID-19
			Conference/Workshop
			7/19/2021
			New Drug Development
			NoSafety Reporting Requirements and Safety Assessment for IND and BA/BE Studies
			Webinar
			6/29/2021
			IND, Safety
			NoIdentification of Medicinal Products: Path to Global Implementation
			Webinar
			6/11/2021
			International, Labeling, Regulatory Submissions
			NoOTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar
			Webinar
			6/3/2021
			OTC Drug Regulation
			NoFDA Study Data Technical Rejection Criteria (TRC): What you need to know!
			Webinar
			5/21/2021
			Regulatory Submissions
			NoFY 2021 Generic Drug Science and Research Initiatives Public Workshop
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoWelcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoGeneric Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoPublic Comment - GDUFA Science and Research Initiatives Public Workshop
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoPanel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoModel-Integrated Evidence for Generic Drug Development – Session 1A
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoModel-Integrated Evidence for Generic Drug Development – Session 1B
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoModel-Integrated Evidence for Generic Drug Development – Session 1C
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoComplex Product Characterization/Analysis - Session 2A
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoComplex Product Characterization/Analysis - Session 2B
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoComplex Product Characterization/Analysis - Session 2C
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoIn Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoIn Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoClosing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA
			Conference/Workshop
			6/23/2021
			Generic Drug Development
			NoFDA and Health Canada Regional ICH Consultation
			Conference/Workshop
			5/14/2021
			Clinical Trials and Research; International; New Drug Development
			NoFDA and Health Canada Regional ICH Consultation - Part I
			Conference/Workshop
			5/14/2021
			Clinical Trials and Research; International; New Drug Development
			NoFDA and Health Canada Regional ICH Consultation - Part II
			Conference/Workshop
			5/14/2021
			Clinical Trials and Research; International; New Drug Development
			NoCommon Labeling Deficiencies and Tips for Generic Drug Applications
			Webinar
			5/7/2021
			Generic Drug Development; Labeling
			NoFDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs
			Webinar
			5/5/2021
			Generic Drug Development; New Drug Development; Orange Book
			NoGeneric Drugs Forum 2021: Lifecycle of a Generic Drug
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoGeneric Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoOffice of Pharmaceutical Quality (OPQ) Update
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoGlobal Generic Drug Landscape
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoData Integrity Issues in Bioequivalence Studies
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoBioavailability/Bioequivalence Site Evaluation During the Pandemic
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoImpact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoGeneric Drugs Forum 2021: Panel Discussion 1
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoOPQ Policy Update
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoUpdate on CDER’s Quality Management Maturity Program
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoGeneric Drugs Forum 2021: Panel Discussion 2
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoPre-ANDA Program
			Conference/Workshop
			4/28/2021
			Generic Drug Development; FDA Meetings/Communications
			NoPre-ANDA Program Update and Tips for Success – OPQ Perspective
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoControlled Correspondence Related to Pharmaceutical Quality
			Conference/Workshop
			4/28/2021
			Generic Drug Development; FDA Meetings/Communications
			NoGeneric Drugs Forum 2021: Panel Discussion 3
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoDivision of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			No>ANDA Labeling: Recommendations and Helpful Resources
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Labeling
			NoGeneric Drugs Forum 2021: Panel Discussion 4
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoAddressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoInsights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoGeneric Drugs Forum 2021: Panel Discussion 5
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoMid-Review Cycle Meeting Overview
			Conference/Workshop
			4/28/2021
			Generic Drug Development; FDA Meetings/Communications
			NoInformation to Include with Cover Letters
			Conference/Workshop
			4/28/2021
			Generic Drug Development; FDA Meetings/Communications
			NoApplication Communications – Quality Assessment Perspective
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoGeneric Drugs Forum 2021: Panel Discussion 6
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoFostering Innovation Through OPQ’s Emerging Technology Program
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoLab Science to Support Generic Complex Drug Product Assessment
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoAssessment of Extractables/Leachables Data in ANDA Submissions
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoGeneric Drugs Forum 2021: Panel Discussion 7
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoBiopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoIntegrated Manufacturing Assessment: Expectations
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoBuilding a Better Sterility Assurance Application
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Drug Quality
			NoGeneric Drugs Forum 2021: Panel Discussion 8
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoPostmarketing Safety and Surveillance of Generic Drugs Update
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoPremarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Safety
			NoUpdate on Shared System REMS for Generic Drug
			Conference/Workshop
			4/28/2021
			Generic Drug Development; Safety
			NoANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoGeneric Drugs Forum 2021: Panel Discussion 9
			Conference/Workshop
			4/28/2021
			Generic Drug Development
			NoDrug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop
			Webinar
			4/9/2021
			Drug Master Files
			NoFDA Safety Report Type Flag Requirement for FAERS Submissions
			Webinar
			2/19/2021
			Regulatory Submissions; Safety
			NoOncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoOncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoInnovation Mindset – Advancing Science to Therapies
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoFDA Oncology Drug Development Overview – Past to Present
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoFederal Resources for Innovative Cancer Startups: More Than Just Funding
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoBest Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoFunding Sources Panel Discussion
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoBuilding Your Network and Value to Obtain External Input Prior to Interacting with FDA
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoAssembling the Best Team to Navigate through Preclinical Development
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoConsulting Companies and FDA Limitations Panel Discussion
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoCMC Considerations for CAR T Cell Product Development
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoCMC Considerations for Oncolytic Viral Product Development
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoPreclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoFDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoOncology Therapy Development Workshop Overview, Day Two
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoChemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoCMC Considerations for Biotechnology Product Development: A Regulatory Perspective
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoGetting to First-in-Human for Small Molecules and Biologics
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoDesigning First-In-Human Trials for Small Molecules and Biologics
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoPlanning for Co-development of Companion Diagnostics
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoClinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoGetting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoOncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion
			Conference/Workshop
			3/30/2021
			New Drug Development; Clinical Trials and Research
			NoDrug Master File (DMF) and Drug Substance Workshop
			Webinar
			3/3/2021
			Drug Master Files
			NoRegulatory Perspectives for Development of Drugs for Treatment of NASH
			Webinar
			1/29/2021
			New Drug Development; Clinical Trials and Research
			NoOTC Monograph Reform in the CARES Act: Safety Orders
			Webinar
			1/27/2021
			OTC Drug Regulation
			NoCDER Compliance Conference
			Conference/Workshop
			1/14/2021
			Compliance, Import/Export; Compounding; DSCSA; Safety
			NoCompounding: Cleanrooms and Cleanroom Behaviors: Why they Matter
			Conference/Workshop
			1/14/2021
			Compliance, Import/Export; Compounding
			NoEnhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates
			Conference/Workshop
			1/14/2021
			Compliance, DSCSA
			NoA Glance at Drug Importation Requirements
			Conference/Workshop
			1/14/2021
			Compliance, Import/Export; Compounding
			NoRisk Evaluation and Mitigation Strategies (REMS) Compliance Program
			Conference/Workshop
			1/14/2021
			Compliance, Safety
			NoDrug Master File (DMF) Submissions on New FDA Form 3938
			Webinar
			1/13/2021
			Drug Master File
			NoDiversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA
			Webinar
			12/16/2020
			Clinical Trials and Research
			NoSEND for CBER, What You Need to Know
			Webninar
			12/4/2020
			Regulatory Submissions
			NoGuidance for Industry: Referencing Approved Drug Products in ANDA Submissions
			Webinar
			11/20/2020
			Generic Drug Development
			NoOffice of Prescription Drug Promotion - Core Launch Review Process
			Webinar
			11/20/2020
			Marketing
			NoBridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients
			Webinar
			11/13/2020
			Labeling
			NoOffice of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available
			Webinar
			11/6/2020
			New Drug Development
			NoCelebrating 40 Years: An In-Depth Examination of the FDA Orange Book
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOpening Remarks and FDA's Orange Book: A Historical Review of 40 Years
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book 101: An Overview of FDA's Orange Book
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoHow to Update Orange Book Information
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoHow to Update Orange Book Information – Panel Discussion
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoAn Overview of FDA's Patent Listing Process
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoChanges to Orange Book Patent Information
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Patent Information – Panel Discussion
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoThe Patent Information Dispute Process
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoBest Practices for 505(b)(2) and ANDA Applicants
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoPatent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity: An Introduction and Overview
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity: Part I - NCE and 3-Year
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity – Panel Discussion
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book Exclusivity – Panel Discussion
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book: An Overview of Therapeutic Equivalence
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoReferencing Approved Drug Products in ANDA Submissions
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoOrange Book: Looking Towards the Future
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoClosing Remarks
			Conference/Workshop
			10/27/2020
			Generic Drug Development; New Drug Development; Orange Book
			NoNew Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment
			Webinar
			10/15/2020
			Drug Development; Clinical Trials and Research
			NoDrug Registration and Listing Workshop
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoDrug Registration and Listing Workshop: Labeler Code Request
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoDrug Registration and Listing Workshop: Establishment Registration
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoDrug Registration and Listing Workshop: Drug Listing
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoDrug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoDrug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program
			Conference/Workshop
			10/8/2020
			Registration and Listing
			NoOverview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs
			Webinar
			10/2/2020
			Drug Quality
			NoAdvancing Innovative Science in Generic Drug Development Workshop
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoDr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoUpdate on GDUFA Science and Research
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoMarch 2020 Transition Under the BPCI Act: Impact on Generics
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoRelated Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoNon-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel Discussion on Method Development / Validations for Non-traditional Analytical Methods
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoDeveloping and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoDeveloping & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoQuantitative Methods for Determining Equivalence of Particle Size Distributions
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoAssessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoIn Vitro Release Testing for Complex Generics: A Bioequivalence Perspective
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoIn Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Development and Validation Considerations for Drug Release and Permeation Testing
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoFormulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoCalculating Maximum Daily Dose (MDD) for Orally Administered Drug Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoWhat’s New in the Inactive Ingredient Database (IID)?
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoLocal Toxicity Considerations for Qualifying Excipients in Generic Drugs
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Excipient and Formulation Considerations
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoIn Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoThe Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoRegional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoTopical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoIn Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoNon-Invasive Raman Spectroscopy-Based Bioequivalence Approaches
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Topical Dermatologic Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPBPK to Guide Study Design and Product Development for Generic Dermatological Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoModel-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Emerging Use of Modeling and Simulation for Bioequivalence
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoBiopharmaceutics Classification System Class 3 Waiver
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoUsing PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoAlternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoA Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoIn Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPractical Considerations for Bioequivalence of GI Locally-Acting Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoPanel on In Vitro Feeding Tube Testing and GI Locally-Acting Products
			Conference/Workshop
			9/29/2020
			Generic Drug Development
			NoCannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations
			Webinar
			9/16/2020
			Drug Master Files
			NoReal-world Evidence for Drugs, Biologics, and Devices - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; Real World Evidence; Postapproval
			NoRestructure of the Office of New Drugs (OND) - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval
			NoSo, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval
			NoOverview of Postmarketing Drug Safety Reporting Requirements - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Safety
			NoDrug Shortages - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Drug Shortages
			NoEnhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; DSCSA
			NoCDER Export Certificate Program - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Import/Export
			NoSBIA Program Overview - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Resources
			NoPost-Approval Submission of Promotional Materials to the OPDP - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Marketing
			NoRequirement for Electronic Submission of an Application and Study Data - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Regulatory Submissions
			NoOverview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Drug Quality
			NoLifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Drug Quality
			NoPost-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Drug Quality
			NoQuestions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Drug Quality
			NoFDA Drug Manufacturing Inspections - REdI 2020
			Conference/Workshop
			8/25/2020
			New Drug Development; NDA; Postapproval; Inspections
			NoBioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoBioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoBioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoBioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoCase Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoCommon Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoConsiderations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoCREST Site Selection Model Overview - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoKeynote - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOffice of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOffice of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOffice of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOffice of Generic Drugs Panel Discussion - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOffice of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoOverview of Immunogenicity Inspections - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoPanel Discussion - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoRegulated Bioanalysis for Small Molecules - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoRegulated Bioanalysis of Large Molecules - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoRegulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoWhat Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis
			Conference/Workshop
			6/30/2020
			Generic Drug Development
			NoKeynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoAn International Commitment to Pharmaceutical Quality (2/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoManufacturing Assessment and Application Action (3/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoPre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; Inspections; International
			NoAn Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; Inspections; International
			NoPanel Discussion (6/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; Inspections; International
			NoFDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoQuality Management Maturity: FDA Vision & Expectations (8/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoMajor Issues and Facilities in Drug Master Files (9/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; Drug Master Files; International
			NoPharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoPanel Discussion (11/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; Drug Master Files; International
			NoFDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoThe State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoSuccessfully Implementing Advanced Manufacturing (14/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoPanel Discussion (15/15) Global Quality
			Webinar
			7/23/2020
			Drug Quality; International
			NoA Pharmaceutical Quality Webinar for Global Stakeholders
			Webinar
			7/23/2020
			Drug Quality; International
			NoCDER SEND Common Issues and Policy Update
			Webinar
			6/15/2020
			Regulatory Submissions
			NoBest Practices for Proprietary Name Design – Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoCombination Products: Reporting Device Information and Malfunctions - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoConsiderations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoDesigning User Interfaces to Prevent Medication Errors – Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoDevelopment of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoDigital IND Safety Reporting - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety; IND
			NoDivision of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoFDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoFDA's Sentinel Initiative - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoKeynote – Pharmacovigilance and Risk Management Conference
			Conference/Workshop
			6/9/2020
			Safety
			NoPostmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoPreventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoProcess for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoQuestions and Discussion – Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoREMS Integration Initiatives - Pharmacovigilance
			Conference/Workshop
			6/9/2020
			Safety
			NoPharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies
			Conference/Workshop
			6/9/2020
			Drug Development; Drug Safety
			NoMonograph reform is here! Learn what to expect and how to prepare.
			Webinar
			5/29/2020
			Regulatory Submissions; OTC Drug Regulation
			NoStill submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead!
			Webinar
			5/26/2020
			Regulatory Submissions
			NoConducting Clinical Trials During the COVID-19 Public Health Emergency
			Webinar
			4/30/2020
			New Drug Development
			NoPostmarketing Drug Safety Compliance: 2019 Inspection Findings
			Webinar
			4/29/2020
			Safety; Inspections
			NoUpdates on FDA’s Drug-Drug Interaction Final Guidances
			Webinar
			4/24/2020
			New Drug Development; IND
			NoGeneric Drugs Forum - April 15&16, 2020
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoANDA Program Performance Review and Tips (8/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoApplication Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoCommon CMC (Quality) Issues and How to Avoid Them Part I (12/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoCommon CMC (Quality) Issues and How to Avoid Them Part II (14/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoCurrent Global Generic Drug Landscape (10/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoElectronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoFacility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoGeneric Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoGeneric Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoKeynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoKeynote: Generic Drug Program Update (1/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoNew Programs and Requirements Under FDARA (5/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoPre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoProduct Specific Guidances (PSGs) (3/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoThe Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum
			Conference/Workshop
			4/15/2020
			Generic Drug Development; Drug Quality
			NoLearn About ClinicalTrials.gov Modernization and How to Provide Input
			Webinar
			3/6/2020
			Clinical Trials and Research
			NoRecent Revisions to the ANDA Prioritization MAPP
			Webinar
			1/30/2020
			Generic Drug Development
			NoImproving Regulatory Communication via the CDER NextGen Portal
			SBIA Chronicles Podcast
			12/29/2019
			Regulatory Submissions
			NoImproving Regulatory Communication via the CDER NextGen Portal
			SBIA Chronicles
			12/19/2019
			Regulatory Submissions
			No2019 CDER Prescription Drug Labeling Conference - December 4-5, 2019
			Conference/Workshop
			12/4/2019
			New Drug Development; Labeling
			NoA Recipe for Clinical Pharmacology Information in Labeling (1/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoAdverse Reaction Information in Prescribing Information (3/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoDrug Product Nomenclature (15/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoImproving the Accuracy of SPL Submissions “The Missing LOINC” (9/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoIndications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoInstructions for Use (IFU) Content and Format Draft Guidance (13/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoLabeling Case Study: Transformation of an Indication (6/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoLabeling Finalization: Final Check of Prescribing Information (8/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoLabeling for Biological Products (11/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPanel Questions and Discussion (10/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPanel Questions and Discussion (16/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPanel Questions and Discussion (19/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPanel Questions and Discussion (7/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPediatric Information In Prescribing Information (4/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoPrescribing Information and Carton/Container Labeling Consistency (18/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoProduct Title & Initial US Approval in the Highlights Section (14/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoSafety Considerations for Container Labels and Carton Labeling (17/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoThe Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19)
			Conference/Workshop
			12/4/2019
			Labeling
			NoVoluntary PLR Conversions and Updating Prescribing Information (1/19)
			Conference/Workshop
			12/4/2019
			Labeling
			No2019 CDER Prescription Drug Labeling Conference
			Conference/Workshop
			12/4/2019
			Labeling
			NoFDA Study Data Technical Conformance Guide v4.4
			Webinar
			11/22/2019
			Regulatory Submissions
			NoClinical Investigator Training Course
			Conference/Workshop
			11/12/2019
			New Drug Development
			NoTechnical Specifications for Submitting Data for QT Studies
			Webinar
			11/8/2019
			Regulatory Submissions
			NoSubmitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)
			Webinar
			11/1/2019
			Safety; IND; Regulatory Submissions
			NoOPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them
			Webinar
			10/25/2019
			Regulatory Submissions; Marketing
			NoCompliance Program and Case Study (7/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoElectronic Drug Registration and Listing Using CDER Direct
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoEstablishment Registration and Labeler Code Requests (3/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoKeynote from the Drug Registration and Listing Staff (2/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoListing Certification and Inactivation (6/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoNDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoPanel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoPanel Questions and Discussion (8/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoWelcome from CDER’s Office of Compliance (1/8) Registration and Listing
			Conference/Workshop
			10/22/2019
			Registration and Listing
			NoApplication Manufacturing Assessment (4/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoAssessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoBiosimilars and Interchangeables - Regulatory Highlights (27/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoCase Studies: Continuous Manufacturing of Drug Substance (21/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoChange Management: ICH Q12 and Established Conditions (12/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoContinuous Manufacturing of Drug Product (20/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoData Quality Expectations for Biosimilars with Case Studies (29/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoEmerging Technology Program (18/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoEnd-to-end Integrated Continuous Manufacturing (25/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoFDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoFDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoFDA’s Quality Assessment and Knowledge Management - KASA (11/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoHow Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoIntegration of Assessment and Inspection for Biological Products (9/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoKeynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (10/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (13/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (17/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (22/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (26/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (30/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (33/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPanel Questions and Discussion (6/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPharmaceutical Quality Surveillance Program (14/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPharmaceutical Quality Symposium
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPolicy Considerations for Continuous Manufacturing (19/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoPolicy Initiatives for Pharmaceutical Quality (5/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoQuality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoQuality Considerations for Transition Biological Products (32/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoQuality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoQuality-Related Compliance Actions and Trends (15/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoSmall Molecule Case Studies (8/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoThe “Deemed to be a License” Provision of the BPCI Act (31/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality; Biosimilars; BLA; NDA
			NoThe Importance of Quality in Our Medicines (2/33) Quality
			Conference/Workshop
			10/16/2019
			Drug Quality
			NoElectronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards
			Webinar
			10/11/2019
			Regulatory Submissions; Safety
			No2019 Complex Generic Drug Product Development Workshop
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoBE Approaches for Long Acting Drug Products (14/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoBE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoBioequivalence for Generic Topical and Transdermal (6/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoCMC Updates for Orally Inhaled Drugs (27/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoComparative Analyses: Device and User Interface (25/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoComparative Analyses: Injectable Combination Products (21/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoComplex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoConsiderations of Particle Analysis (12/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoCREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoDose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoFDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoGeneric Topical and Transdermal Products (5/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoIn Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoKeynote with Sally Choe (1/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoOverview of Comparative Analyses - Clinical Perspective (19/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPanel Questions and Discussion (35/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPhysiologically-based Pharmacokinetic Modeling (32/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPre-ANDA Program Update (2/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoPSG Recommendations and Updates for OINDPs (23/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuality for Transdermal Delivery Systems (8/35) Complex Generic Drugs
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuality View on Injectable Product Considerations (20/35) Complex Generic Drugs
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuantitative Methods and Modeling (29/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (13/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (17/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (22/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (28/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (4/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (9/35) Complex Generic Drugs
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoStrategies for Generic Topical Product Development (7/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoStrategies to Demonstrate Complex API Sameness (10/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoStrategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoWhat Constitutes Complex Drug-Device Combination (18/35) Complex Generics
			Conference/Workshop
			9/25/2019
			Generic Drug Development; Drug Quality
			NoREdI and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls
			Conference/Workshop
			9/23/2019
			New Drug Development
			NoAbbreviated Approval Pathways - 505(b)(2) or ANDA?
			SBIA Chronicles
			9/19/2019
			Generic Drug Development; NDA
			NoAbbreviated Approval Pathways - 505(b)(2) or ANDA?
			SBIA Chronicles Podcast
			9/19/2019
			Generic Drug Development; NDA
			NoMost Common Issues with CDISC-SEND Data in FDA Toxicology Review
			Webinar
			9/12/2019
			Regulatory Submissions
			NoeCTD Submissions of Promotional Labeling and Advertising Materials
			Webinar
			8/12/2019
			Regulatory Submissions; Marketing
			NoRisk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment
			Webinar
			6/26/2019
			Clinical Trials and Research
			NoResearch Investigational New Drug Applications – What You Need To Know
			SBIA Chronicles
			6/25/2019
			Clinical Trials and Research; IND
			NoResearch Investigational New Drug Applications – What You Need To Know
			SBIA Chronicles Podcast
			6/25/2019
			Clinical Trials and Research; IND
			NoBioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections
			Webinar
			6/17/2019
			Generic Drug Development
			NoAccuracy and Precision in Bioanalysis: Review of Case Studies
			Webinar
			6/17/2019
			New Drug Development
			NoBioanalytical Method Validation (BMV) Panel Discussion
			Webinar
			6/17/2019
			New Drug Development
			NoBioanalytical Inspections: Overview and Case Studies
			Webinar
			6/17/2019
			New Drug Development
			NoHow should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV)
			Webinar
			6/17/2019
			New Drug Development
			NoThe Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs
			Webinar
			6/17/2019
			New Drug Development; NDA; BLA
			NoIdentification of Medicinal Products (IDMP): What is IDMP and Why Should I Care?
			Webinar
			6/13/2019
			New Drug Development
			NoCDER FDA Exclusivity – Which One Is for Me?
			Webinar
			6/10/2019
			User Fees; NDA; BLA
			NoFDA Orphan Drugs Program and Financial Incentives for CDER Medical Products
			Webinar
			6/10/2019
			User Fees; NDA; BLA
			NoFinancial Incentives for CDER Medical Products
			Webinar
			6/10/2019
			User Fees; NDA; BLA
			NoNavigating the World of Biosimilar User Fees
			Webinar
			6/10/2019
			BLA; User Fees
			NoPanel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars
			Webinar
			6/10/2019
			User Fees; NDA; BLA
			NoPrescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My
			Webinar
			6/10/2019
			User Fees; NDA; BLA
			NoA Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference
			Conference/Workshop
			5/29/2019
			New Drug Development; IND; Resources
			NoCDER Industry Assistance Resources (1/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND; Resources
			NoCDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoCMC - NDA requirements and Common Pitfalls of BLAs (14/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoComponents of New Drug Application and Biologics License Application (5/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoElectronic Common Technical Document (eCTD) and Study Data (7/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoMeetings: Pre-submission and Special Programs (4/15) REdI Annual Conference
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoNavigating the World of Combination Products (2/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoNDA and BLA Application Review Process (6/15) REdI Annual Conference
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoNonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoORA Aligned for the Future (1/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoPre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND; Inspections
			NoReady to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND; Marketing
			NoRegulatory Education for Industry (REdI) Annual Conference - Focus on Essentials of NDAs and BLAs
			Conference/Workshop
			5/29/2019
			User Fees; NDA; BLA
			NoRegulatory Highlights for Biosimilars and Interchangeables (9/15) REdI
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoWhat can CDER do for you? (3/15) REdI Annual Conference
			Conference/Workshop
			5/29/2019
			New Drug Development; IND
			NoCompetitive Generic Therapies
			SBIA Chronicles
			5/23/2019
			Generic Drug Development
			NoCompetitive Generic Therapies
			SBIA Chronicles Podcast
			5/23/2019
			Generic Drug Development
			NoAn Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies
			Webinar
			5/9/2019
			Clinical Trials and Research
			NoDeploying the MyStudies System in a Compliant Manner (8/9) MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoFinal Question and Answer Panel (9/9) MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoIntroduction (1/9) FDA MyStudies Mobile App System
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoMobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoPatient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoPatient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9)
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoQuestion and Answer Panel (7/9) MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoQuestion and Answer Session Martin and Wyner (4/9) FDA MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			NoResponse Server Technical Overview (6/9) FDA MyStudies App
			Webinar
			5/9/2019
			New Drug Development; Real World Evidence
			No505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoAssessment Tips (17/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoCase Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoComplex Product Development (3/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoContinuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoDecrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoDeficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoDrug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoFiling and Refuse to Receive (RTR) (16/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoGeneric Drug Forum: April 3-4, 2019
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoImpurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoKeynote: Generic Drug Program Update (1/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoManufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoMid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoOrange Book - Its Role in ANDAs (8/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoPractical Tips on eCTD (13/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoPre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (11/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (15/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (19/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (23/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (28/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoQuestions and Answers (5/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoReferencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoStability Case Studies (20/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoThe Importance of Quality in Our Medicines (2/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoTips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoTypes of Fees and Q&A (24/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoUpdate on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum
			Conference/Workshop
			4/3/2019
			Generic Drug Development; Drug Quality
			NoA New Era for Homeopathic Drug Product Regulation
			SBIA Chronicles Podcast
			3/22/2019
			New Drug Development
			NoFramework for FDA’s Real-World Evidence Program
			Webinar
			3/15/2019
			New Drug Development; Real World Evidence
			NoHuman Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course 1

			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			3/12/2019
			Registration and Listing
			NoFDA Modernizes Clinical Trials with Master Protocols
			SBIA Chronicles
			2/26/2019
			New Drug Development; IND; Clinical Trials and Research
			NoFDA Modernizes Clinical Trials with Master Protocols
			SBIA Chronicles Podcast
			2/26/2019
			New Drug Development; IND; Clinical Trials and Research
			NoFinal Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations
			Webinar
			12/6/2018
			Clinical Trials and Research; Regulatory Submissions
			NoEarly Engagement with FDA to Discuss Novel Surrogate Endpoints
			SBIA Chronicles
			11/27/2018
			New Drug Development; FDA Meetings/Communications
			NoEarly Engagement with FDA to Discuss Novel Surrogate Endpoints
			SBIA Chronicles Podcast
			11/27/2018
			New Drug Development; FDA Meetings/Communications
			NoFDA Study Data Technical Conformance Guide
			Webinar
			11/27/2018
			Regulatory Submissions
			NoClinical Investigator Training Course (CITC) 2018: November 13 - 15, 2018
			Conference/Workshop
			11/13/2018
			New Drug Development; Clinical Trials
			NoFDA Facilitates the Use of Surrogate Endpoints in Drug Development
			SBIA Chronicles
			11/5/2018
			Clinical Trials and Research; IND
			NoFDA Facilitates the Use of Surrogate Endpoints in Drug Development
			SBIA Chronicles Podcast
			11/5/2018
			Clinical Trials and Research; IND
			NoA Case Example of the Review of Audit Trails in GCP Inspections (11/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoBlinding of Bioequivalence Trials (9/11) GCP Data Integrity
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoData Integrity from International Perspectives (2/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoData Quality: Why Do We Care? (1/11) GCP Data Integrity
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoEffective Use of Audit Trails (10/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoFDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials - Are We There Yet?: October 23-24, 2018
			Conference/Workshop
			10/23/2018
			New Drug Development; Clinical Trials and Research
			NoGood Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoOverview of Data Integrity (4/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoQuality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoQuality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoThe Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoUnblinding – Let Me Count the Ways... (8/11) GCP Data Integrity
			Conference/Workshop
			10/23/2018
			Clinical Trials and Research
			NoElectronic Drug Registration and Listing Using CDER Direct: October 2, 2018
			Conference/Workshop
			10/2/2018
			Registration and Listing
			NoWriting the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance
			Webinar
			9/27/2018
			Labeling
			NoReal-Time Review of Drug Applications is Now a Reality
			SBIA Chronicles
			9/20/2018
			IND; NDA
			NoReal-Time Review of Drug Applications is Now a Reality
			SBIA Chronicles Podcast
			9/20/2018
			IND; NDA
			NoComplex Generic Drug Product Development Workshop
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoCommon Issues in Complex Drug Substance Review (8of39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoConsiderations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics '18
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoConsiderations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoEquivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39)
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoEstablishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoIn vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoIn Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoIron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoMultivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39)
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoOffice of Generic Drugs Keynote (1/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoPBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39)
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoPeptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoPre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoPre-ANDA Program Overview (2/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoPre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoProduct Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoQuestions and Panel Discussion (16/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoQuestions and Panel Discussion (20/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoQuestions and Panel Discussion (5/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoQuestions and Panel Discussion (9/39) Complex Generics 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoComplex Generic Drug Product Development Workshop - September 12-13, 2018
			Conference/Workshop
			9/12/2018
			Generic Drug Development; Drug Quality
			NoThe FAERS Public Dashboard and its Value to the Pharmaceutical Industry
			SBIA Chronicles
			7/10/2018
			Safety
			NoThe FAERS Public Dashboard and its Value to the Pharmaceutical Industry
			SBIA Chronicles Podcast
			7/10/2018
			Safety
			NoPostmarketing Drug Safety and Inspection Readiness - June 19, 2018 Deeper Dive Webinar
			Webinar
			6/19/2018
			Inspections; Safety; Postapproval
			NoBIMO, REMS, and PADE Inspection Readiness (3/3)
			Webinar
			6/19/2018
			Safety; Inspections; Postapproval
			NoPostmarketing Adverse Drug Experience (PADE) Inspections – (1/3)
			Webinar
			6/19/2018
			Safety; Inspections; Postapproval
			NoRisk Evaluation and Mitigation Strategies (REMS) Inspections (2/3)
			Webinar
			6/19/2018
			Safety; Inspections; Postapproval
			NoBenefit-Risk Considerations During Drug Product Development (8/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoCDER Small Business and Industry Assistance Overview (12/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA; Resources
			NoChemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoDemystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoFDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoFormal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoGood Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoHuman Factors Engineering in Medical Products Reviews (2/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoInvestigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoInvestigational New Drug Safety Reporting Requirements (10/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoNonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoOffice of Regulatory Affairs Update (1/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoPanel Discussion (27/27) Generic Drugs Forum April 11-12, 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoThe Active IND and Available Development Programs (13/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoWalkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018
			Conference/Workshop
			5/18/2018
			Drug Development; IND; NDA
			NoRegulatory Education for Industry (REdI) Spring Conference:  May 15-16, 2018
			Conference/Workshop
			5/15/2018
			New Drug Development; IND
			NoOptimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission
			Webinar
			5/8/2018
			Regulatory Submissions
			NoUpdates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products
			Webinar
			5/4/2018
			Regulatory Submissions
			NoANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoApplication Communications: RBPM Communication with Industry throughout the IQA (24/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoBest Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoBioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoChallenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoDetermining Whether to Submit an ANDA or a 505(b)(2) Application (12/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoDrug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoElectronic Submissions (7/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Regulatory Submissions
			NoFiling Review Basics – Examples of Refuse-to-Receive (RTR) (15/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoGDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoGDUFA II Pre-ANDA Program Meetings: Advice for Success (10/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality; FDA Meetings/Communications
			NoGDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoGeneric Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoGeneric Drugs Forum: April 11 -12, 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development
			NoGood ANDA Submission and Assessment Practices and Software Support (5/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoIntegrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoIntegrated Quality Assessment Process (19/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoKeynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoLaboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoMicrobiology Quality Assessment (18/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoOffice of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoOrange Book: 101 An Overview (11/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoPanel Discussion (13/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoPanel Discussion (20/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoPanel Discussion (9/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoPharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoUsing the ePortal to Submit a pre-ANDA Meeting (8/27) Generic Drugs Forum 2018
			Conference/Workshop
			4/11/2018
			Generic Drug Development; Drug Quality
			NoA New Era for Homeopathic Drug Product Regulation
			SBIA Chronicles
			3/22/2018
			New Drug Development
			NoA New Era for Homeopathic Drug Product Regulation
			SBIA Chronicles Podcast
			3/22/2018
			New Drug Development
			NoFDA Helping the Generic Industry Submit Complete Applications
			SBIA Chronicles
			2/6/2018
			Generic Drug Development; Regulatory Submissions
			NoFDA Helping the Generic Industry Submit Complete Applications
			SBIA Chronicles Podcast
			2/6/2018
			Generic Drug Development; Regulatory Submissions
			NoDraft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA
			Webinar
			12/18/2017
			Generic Drug Development; Regulatory Submissions
			NoREMS Integration Initiative: An Overview
			Webinar
			12/4/2017
			Safety
			NoPDUFA VI - A Time for Change
			SBIA Chronicles
			11/28/2017
			User Fees; NDA
			NoPDUFA VI - A Time for Change
			SBIA Chronicles Podcast
			11/28/2017
			User Fees; NDA
			NoOptimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update
			Webinar
			11/8/2017
			Regulatory Submissions
			NoPrescription Drug Labeling Conference 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoDraft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
			Webinar
			11/2/2017
			Generic Drug Development
			NoPLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoConsistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoConsiderations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoConverting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoNovel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoCracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoOverview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoLessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoSafety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017
			Conference/Workshop
			11/2/2017
			Labeling
			NoDraft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA
			Webinar
			11/1/2017
			Generic Drug Development; FDA Meetings/Communications
			NoDraft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application
			Webinar
			10/13/2017
			Generic Drug Development; NDA
			NoElectronic Drug Registration & Listing Using CDER Direct: Extended Webinar
			Webinar
			10/5/2017
			Registration and Listing
			NoDraft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
			Webinar
			10/2/2017
			Generic Drug Development; FDA Meetings/Communications
			NoRegulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoKeynote (1/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoPlenary: Regulatory Research at FDA (2/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoIntroduction to Investigational New Drug (IND) Applications (3/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoFDA Communication During Drug Development (4/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; FDA Meetings/Communications
			NoRegulatory and Administrative Components of an IND Application (5/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; Regulatory Submissions
			NoBenefit-Risk Considerations in Drug Development (6/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoChemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; Drug Quality
			NoOverview of Non-clinical Assessment in Drug Development (8/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoSubmit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; Regulatory Submissions
			NoAdditional Sponsor Responsibilities (10/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoOverview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoWalkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; Inspections
			NoOverview of FDA's Expanded Access Program (13/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND
			NoLive Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017
			Conference/Workshop
			9/27/2017
			New Drug Development; IND; Drug Safety
			NoReal-World Data and Evidence in Drug Development
			SBIA Chronicles
			8/24/2017
			New Drug Development
			NoElectronic Common Technical Document (eCTD): CDERLearn Course 1

			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			8/3/2017
			Regulatory Submissions
			NoOptimizing Your Study Data Submissions to FDA – Updates from CDER and CBER
			Webinar
			7/13/2017
			Regulatory Submissions
			NoUpdates to the Study Data Technical Conformance Guide (1/4) Technical Conformance
			Webinar
			7/13/2017
			Regulatory Submissions
			NoProviding Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance
			Webinar
			7/13/2017
			Regulatory Submissions
			NoBiologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance
			Webinar
			7/13/2017
			Regulatory Submissions
			NoPanel Questions and Discussion (4/4) Study Data Technical Conformance Webinar
			Webinar
			7/13/2017
			Regulatory Submissions
			NoDraft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II II
			Webinar
			7/5/2017
			Generic Drug Development; Regulatory Submissions
			NoPresenting Clinical Pharmacology Information in Prescription Drug Labeling
			Webinar
			6/19/2017
			Labeling
			NoRisk Evaluation and Mitigation Strategies (REMS): A Deeper Dive
			Webinar
			6/15/2017
			New Drug Development; Safety
			NoREMS Purpose, Process, and Challenges (1/2) REMS Webinar
			Webinar
			6/15/2017
			New Drug Development; Safety
			NoStructured Product Labeling Format: An Introduction (2/2) REMS Webinar
			Webinar
			6/15/2017
			New Drug Development; Safety; Regulatory Submissions
			NoSubmitting Master Files in eCTD Format: When and How to Comply
			SBIA Chronicles
			5/25/2017
			Drug Master Files; Regulatory Submissions
			NoSubmitting Master Files in eCTD Format: When and How to Comply
			SBIA Chronicles Podcast
			5/25/2017
			Drug Master Files; Regulatory Submissions
			NoRegulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017
			Conference/Workshop
			5/9/2017
			New Drug Development; IND
			NoThe Complexities of Compounding
			SBIA Chronicles
			4/20/2017
			Compounding
			NoThe Complexities of Compounding
			SBIA Chronicles Podcast
			4/20/2017
			Compounding
			NoGeneric Drugs Forum: April 4-5, 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoKeynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoKeynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoOffice of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoGDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoPreparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoeCTD (7/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Regulatory Submissions
			NoPanel Discussion (8/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Regulatory Submissions; Drug Quality
			NoGDUFA II (9/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; User Fees
			NoDevelopment of Single, Shared System REMS (10/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Safety
			NoIntroduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoPanel Discussion (13/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoFiling Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Regulatory Submissions
			NoRPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoFDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoReview of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoGeneric Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Labeling
			NoPanel Discussion (19/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development
			NoOPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoOPQ Communications with Industry (21/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoDrug Substance Review - ANDA (22/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoGeneric Drug Product Quality Review (23/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoDissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoManufacturing Process and Controls (25/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoFacility Evaluation and Inspection (26/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality; Inspections
			NoProduct Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality
			NoPanel Discussion (28/28) Generic Drugs Forum 2017
			Conference/Workshop
			4/4/2017
			Generic Drug Development; Drug Quality; Inspections
			NoCDER Microbiology Issues: A Deeper Dive
			Webinar
			3/15/2017
			Drug Quality
			NoMicrobiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoCase Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoPanel Questions and Discussion (3/6) CDER Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoBuilding a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoAseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoPanel Questions and Discussion (6/6) CDER Microbiology Webinar
			Webinar
			3/15/2017
			Drug Quality
			NoDraft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions
			Webinar
			3/6/2017
			Generic Drug Development
			NoBest Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			2/1/2017
			FDA Meetings/Communications; IND
			NoFDA Addresses Small Business Concerns in GDUFA II
			SBIA Chronicles
			1/26/2017
			Generic Drug Development
			NoFDA Addresses Small Business Concerns in GDUFA II
			SBIA Chronicles Podcast
			1/26/2017
			Generic Drug Development
			NoFDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			6/7/2021
			New Drug Development; Safety; Quality
			NoGDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			1/12/2016
			Generic Drug Development; Regulatory Submissions
			NoGDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course 1

			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			1/12/2016
			Generic Drug Development; Regulatory Submissions
			NoOverview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			1/12/2016
			Generic Drug Development; User Fees
			NoCase Studies in FDA's Drug Regulatory Processes: CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			10/22/2015
			New Drug Development; NDA; IND
			NoEngaging with the FDA During New Drug Development 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			9/26/2014
			New Drug Development; FDA Meetings/Communications
			NoChemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course 1
 
			Certificates of completion and embedded videos are no longer available.
			CDERLearn Course
			9/17/2014
			New Drug Development; Drug Quality
			NoCDER Presentations Library
			Webinar
			
			New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research
			NoCDER Webinars
			Webinar
			
			New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research
			NoGuidance Webinar Series
			Webinar
			
			New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research
			No

Program Overview






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      01/23/2024
              
              
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