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                CDER Small Business & Industry Assistance (SBIA)

CDER Small Business & Industry Assistance (SBIA)

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Topic About FDA and CDERBiologics, Biosimilars, Biologics License Application (BLA)Clinical Trials, Drug Development and ApprovalCompliance, Inspections, EnforcementCompoundingDatabasesDrug Master FilesDrug Safety, RecallsDrug Supply ChainGeneric Drugs, Abbreviated New Drug Application (ANDA)Import/Export, Regulatory Affairs, International ProgramsInvestigational New Drug Application (IND)LabelingMeetings, Engaging with FDANew Drug Review, New Drug Application (NDA)Over-the-Counter Drug ReviewPharmaceutical Quality and ManufacturingPost-Marketing Activities and PromotionRare Diseases and Orphan DrugsRegistration and ListingRegulations, Laws, GuidancesReportsSubmissions, Forms, ContactsTraining ResourcesUser Fees


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			TopicsSearch for Pharmaceutical Quality Documents
			Pharmaceutical Quality and ManufacturingMultiple Endpoints Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalEthical Considerations for Clinical Investigations Involving Children -Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalNeonatal Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPatient-Focused Drug Development Clinical Outcome Assessments
			Guidance
			Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalFood Effects Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalBioavailability Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPopulation Pharmacokinetics Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPathology Peer Review Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalBenefit-Risk Assessment for New Drug and Biologic Products Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalAdjusting for Covariates Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalIn Vitro Drug Interaction Studies Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalClinical Drug Interaction Studies Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalComplex Innovative Trial Designs Guidance Snapshot
			Regulations, Laws, Guidances; Meetings, Engaging with FDAMaximal Usage Trials Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalTargeted Therapies Guidance Snapshot
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalMultiple Endpoints Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalEthical Considerations for Clinical Investigations Involving Children -Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalNeonatal Studies Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPatient-Focused Drug Development Clinical Outcome Assessments
			Guidance Recap
			Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalFood Effects Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalBioavailability Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPopulation Pharmacokinetics Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalPathology Peer Review Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalAdjusting for Covariates Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalIn Vitro Drug Interaction Studies Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalClinical Drug Interaction Studies Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Clinical Trials, Drug Development and ApprovalComplex Innovative Trial Designs Guidance Recap Podcast Transcript
			Regulations, Laws, Guidances; Meetings, Engaging with FDAComplex Generics News
			Generic Drugs, Abbreviated New Drug ApplicationsEmerging Technology Program
			Pharmaceutical Quality and ManufacturingOncology Regulatory Expertise and Early Guidance (OREEG)
			Clinical Trials, Drug Development and Approval, Investigational New Drug Development Application (IND), Meetings, Engaging with FDAOTC Monographs@FDA
			Over-the-Counter Drug ReviewOver-the-Counter (OTC) Drug Review | OTC Monograph Reform in the CARES Act
			Over-the-Counter Drug ReviewPhonetic and Orthographic Computer Analysis (POCA) Program
			Drug Safety; Clinical Trials, Drug Development and ApprovalAbout CDER Small Business and Industry Assistance
			About FDA and CDERAbout FDA
			About FDA and CDERCDER Exclusivity Board
			About FDA and CDERCDER Ombudsman
			About FDA and CDERDoing Business With FDA
			About FDA and CDERJobs at FDA
			About FDA and CDERBiosimilar Development, Review, and Approval
			Biologics, Biosimilars, Biologics License Application (BLA)Biosimilar Product Information (FDA-Approved List of Biological Products)
			Biologics, Biosimilars, Biologics License Application (BLA)Biosimilars
			Biologics, Biosimilars, Biologics License Application (BLA)Biosimilars Action Plan
			Biologics, Biosimilars, Biologics License Application (BLA)Bisoimilar Industry Information and Guidance
			Biologics, Biosimilars, Biologics License Application (BLA)"Deemed to be a License” Provision of the BPCI Act
			Biologics, Biosimilars, Biologics License Application (BLA)Frequently Asked Questions About Therapeutic Biological Products
			Biologics, Biosimilars, Biologics License Application (BLA)Therapeutic Biologic Applications (BLA) Approval Information
			Biologics, Biosimilars, Biologics License Application (BLA)Transfer of Therapeutic Products to CDER
			Biologics, Biosimilars, Biologics License Application (BLA)Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations
			Biologics, Biosimilars, Biologics License Application (BLA); DatabasesBiosimilar User Fee Amendments (BsUFA)
			Biologics, Biosimilars, Biologics License Application (BLA); User FeesBiomarker Qualification Program
			Clinical Trials, Drug Development and ApprovalCombination Products
			Clinical Trials, Drug Development and ApprovalClinical Trials and Human Subject Protection
			Clinical Trials, Drug Development and ApprovalDevelopment & Approval Process
			Clinical Trials, Drug Development and ApprovalDrug Development and Drug Interactions: Table of Substrates, Inhibitors and Inducers
			Clinical Trials, Drug Development and ApprovalDrug Development Process
			Clinical Trials, Drug Development and ApprovalThe FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
			Clinical Trials, Drug Development and ApprovalEconomic Assistance and Incentives for Drug Development
			Clinical Trials, Drug Development and ApprovalCoronavirus (COVID-19)
			Clinical Trials, Drug Development and ApprovalCOVID MyStudies Application (App)
			Clinical Trials, Drug Development and ApprovalFrequently Asked Questions on Patents and Exclusivity
			Clinical Trials, Drug Development and ApprovalReal-World Evidence
			Clinical Trials, Drug Development and ApprovalCompliance Actions and Activities
			Compliance, Inspections, EnforcementInspections, Compliance, Enforcement, and Criminal Investigations
			Compliance, Inspections, EnforcementUnapproved Drugs
			Compliance, Inspections, EnforcementWarning Letters and Notice of Violation Letters to Pharmaceutical Companies
			Compliance, Inspections, EnforcementCompounding and the FDA: Questions and Answers
			CompoundingCompounding Risk Alerts
			CompoundingCompounding: Inspections, Recalls, and other Actions
			CompoundingHuman Drug Compounding
			CompoundingAcronyms and Abbreviations Search
			DatabasesDrug Approvals and Databases
			DatabasesDrugs@FDA
			DatabasesFDALabel
			DatabasesInactive Ingredient Database
			DatabasesNational Drug Code Directory
			DatabasesDrug Shortages
			DatabasesSearch List of Extended Use Dates to Assist with Drug Shortages
			DatabasesApproved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
			Databases; Generic Drugs, Abbreviated New Drug Application (ANDA)Drug Master File webpage
			Drug Master FilesDrug Master Files: Guidelines
			Drug Master FilesType II DMFs for Active Pharmaceutical Ingredients
			Drug Master FilesTypes of Drug Master Files (DMFs)
			Drug Master FilesDrug Recalls
			Drug Safety, RecallsDrug Safety Communications
			Drug Safety, RecallsFDA Adverse Event Reporting System (FAERS) Public Dashboard
			Drug Safety, RecallsMedwatch
			Drug Safety, RecallsPreventable Adverse Drug Reactions: A Focus on Drug Interactions
			Drug Safety, RecallsRisk Evaluation and Mitigation Strategies (REMS)
			Drug Safety, RecallsDrug Safety Labeling Changes
			Drug Safety, Recalls; LabelingFDA Adverse Event Reporting System (FAERS) Electronic Submissions
			Drug Safety, Recalls; Submissions, Forms, ContactsMedwatch Reporting for Industry
			Drug Safety, Recalls; Submissions, Forms, ContactsDrug Safety and Availability
			Drug Safety; DatabasesDrug Supply Chain Integrity
			Drug Supply ChainDrug Supply Chain Security Act
			Drug Supply ChainVerify Wholesale Drug Distributor Licenses
			Drug Supply ChainAbbreviated New Drug Application (ANDA)
			Generic Drugs, Abbreviated New Drug Application (ANDA)Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
			Generic Drugs, Abbreviated New Drug Application (ANDA)Dissolution Methods Database
			Generic Drugs, Abbreviated New Drug Application (ANDA)First Generic Drug Approvals
			Generic Drugs, Abbreviated New Drug Application (ANDA)Generic Drug Research-Related Guidances and Reports
			Generic Drugs, Abbreviated New Drug Application (ANDA)Generic Drugs: Information for Industry
			Generic Drugs, Abbreviated New Drug Application (ANDA)Guidance Documents for Generic Drugs (search Generics under topic)
			Generic Drugs, Abbreviated New Drug Application (ANDA)Guidance for Industry: ANDA Submission - Content and Format of ANDAs
			Generic Drugs, Abbreviated New Drug Application (ANDA)Orange Book Preface
			Generic Drugs, Abbreviated New Drug Application (ANDA)Patent Certifications and Suitability Petitions
			Generic Drugs, Abbreviated New Drug Application (ANDA)Product-Specific Guidances for Generic Drug Development
			Generic Drugs, Abbreviated New Drug Application (ANDA)Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
			Generic Drugs, Abbreviated New Drug Application (ANDA)Self-Identification of Generic Drug Facilities, Sites and Organizations
			Generic Drugs, Abbreviated New Drug Application (ANDA)Pre-ANDA Program
			Generic Drugs, Abbreviated New Drug Application (ANDA); Meetings, Engaging with FDAFDA List of Authorized Generic Drugs
			Generic Drugs, Abbreviated New Drug Application (ANDA); New Drug Review, New Drug Application (NDA)ANDA Forms and Submissions Requirements
			Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, ContactsControlled Correspondence
			Generic Drugs, Abbreviated New Drug Application (ANDA); Submissions, Forms, ContactsGDUFA web-based learning courses
			Generic Drugs, Abbreviated New Drug Application (ANDA); User FeesGeneric Drug User Fee Amendments (GDUFA)
			Generic Drugs, Abbreviated New Drug Application (ANDA); User FeesExport certificates
			Import/Export, Regulatory Affairs, International ProgramsImport and Export of Human Drugs and Biologics
			Import/Export, Regulatory Affairs, International ProgramsInformation for Exporters
			Import/Export, Regulatory Affairs, International ProgramsOffice of Global Policy and Strategy
			Import/Export, Regulatory Affairs, International ProgramsOffice of Regulatory Affairs (ORA) Directory
			Import/Export, Regulatory Affairs, International Programs; Submissions, Forms, ContactsExpanded Access: Information for Industry
			Investigational New Drug Application (IND)Expedited Programs
			Investigational New Drug Application (IND)Exploratory INDs
			Investigational New Drug Application (IND)IND Exemptions
			Investigational New Drug Application (IND)Investigational New Drug (IND) Application
			Investigational New Drug Application (IND)Investigator-Initiated INDs and IND submission procedures
			Investigational New Drug Application (IND)Pregnancy and Lactation Labeling (Drugs) Final Rule
			LabelingFDA’s Labeling Resources for Human Prescription Drugs
			LabelingTable of Pharmacogenomic Biomarkers in Drug Labeling
			LabelingMedication Guides
			Labeling; DatabasesAdvisory Committees (human drugs)
			Meetings, Engaging with FDABest Practices for Communication Between IND Sponsors and FDA During Drug Development
			Meetings, Engaging with FDAEngaging with FDA during New Drug Development CDERLearn Course
			Meetings, Engaging with FDANews & Events for Human Drugs
			Meetings, Engaging with FDA; About FDA and CDERFormal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Guidance for Industry
			Meetings, Engaging with FDA; Generic Drugs, Abbreviated New Drug Application (ANDA)Pre-IND Meeting FAQs
			Meetings, Engaging with FDA; Investigational New Drug Application (IND)Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry
			Meetings, Engaging with FDA;
			Biologics, Biosimilars, Biologics License Application (BLA)Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products
			Meetings, Engaging with FDA;
			Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA)New Drug Application (NDA) Resources
			New Drug Review, New Drug Application (NDA)Pre-IND Consultation Program
			New Drug Review, New Drug Application (NDA)Requesting a Pre-Assigned Application number
			New Drug Review, New Drug Application (NDA)Coronavirus Treatment Acceleration Program (CTAP)
			New Drug Review, New Drug Application (NDA); Clinical Trials, Drug Development and ApprovalApplications Covered by Section 505(b)2) Guidance for Industry
			New Drug Review, New Drug Application (NDA); Investigational New Drug Application (IND)Prescription Drug User Fee Amendments (PDUFA)
			New Drug Review, New Drug Application (NDA); User FeesUser Fee Waivers, Reduction, and Refunds for Drug and Biological Products - Guidance for Industry
			New Drug Review, New Drug Application (NDA); User FeesDevelopment and Regulation of OTC (Nonprescription) Drugs
			Over-the-Counter Drug ReviewDrug applications for OTC drugs
			Over-the-Counter Drug ReviewOTC Monographs and Rulemaking
			Over-the-Counter Drug ReviewOver-the-Counter (OTC) Drug Monograph Process
			Over-the-Counter Drug ReviewOver-the-Counter Monograph User Fee Program (OMUFA)
			Over-the-Counter Drug Review; User FeesBlackBerry QNX Cybersecurity Vulnerabilities May Affect Drug Manufacturing Equipment
			Pharmaceutical Quality and ManufacturingCurrent Good Manufacturing Practice (CGMP) Regulations
			Pharmaceutical Quality and ManufacturingDeveloping and Manufacturing Drugs Including Biologics
			Pharmaceutical Quality and ManufacturingDrug Quality Sampling and Testing Programs
			Pharmaceutical Quality and ManufacturingExpiration Dates - Questions and Answers
			Pharmaceutical Quality and ManufacturingFacts About CGMPs
			Pharmaceutical Quality and ManufacturingPharmaceutical Quality Resources
			Pharmaceutical Quality and ManufacturingQuality Metrics for Drug Manufacturing
			Pharmaceutical Quality and ManufacturingQuestions and Answers on CGMPs
			Pharmaceutical Quality and ManufacturingQuestions and Answers on Current Good Manufacturing Practices—Control of Components and Drug Product Containers and Closures
			Pharmaceutical Quality and ManufacturingQuestions and Answers on Current Good Manufacturing Practices—Production and Process Controls
			Pharmaceutical Quality and ManufacturingReport a Product Quality Issue
			Pharmaceutical Quality and ManufacturingCurrent Good Manufacturing Practice (CGMP) Regulations
			Pharmaceutical Quality and Manufacturing; Regulations, Laws, GuidancesOffice of Prescription Drug Promotion (OPDP)
			Post-Marketing Activities and PromotionTruthful Prescription Drug Advertising and Promotion (Bad Ad Program)
			Post-Marketing Activities and PromotionPostmarket Drug Safety Information for Patients and Providers
			Post-Marketing Activities and Promotion; Drug SafetyPostmarketing Surveillance Programs
			Post-Marketing Activities and Promotion; Drug SafetyDeveloping Products for Rare Diseases and Conditions
			Rare Diseases and Orphan DrugsFrequently Asked Questions (FAQ) About Designating an Orphan Product
			Rare Diseases and Orphan DrugsSearch Orphan Drug Designations and Approvals
			Rare Diseases and Orphan DrugsCDER Direct: Electronic Submissions Portal
			Registration and ListingElectronic Drug Registration and Listing Instructions
			Registration and ListingDrug Establishments Current Registration Site (DECRS Database)
			Registration and Listing; DatabasesRegistered Outsourcing Facilities (Compounding)
			Registration and Listing; DatabasesCode of Federal Regulations, Title 21
			Regulations, Laws, GuidancesFederal Food Drug & Cosmetic Act
			Regulations, Laws, GuidancesLaws, Regulations and Guidances
			Regulations, Laws, GuidancesNewly Added Guidance Documents
			Regulations, Laws, GuidancesSearch for FDA Guidance Documents
			Regulations, Laws, GuidancesCDER Reports & Budget
			ReportsDivision of Applied Regulatory Science Annual Reports
			ReportsDrug and Biologic Approval and IND Activity Reports
			ReportsFast Track Approvals
			ReportsGDUFA Science and Research Reports
			ReportsIND Application Reporting: Safety Reports
			ReportsNDA and BLA Approvals
			ReportsNDA and BLA Calendar Year Approvals
			ReportsOffice of Clinical Pharmacology Annual Reports
			ReportsOffice of Generic Drugs Annual Reports
			ReportsOffice of New Drugs Annual Reports
			ReportsOffice of Pharmaceutical Quality Annual Reports
			ReportsCDER Data Standards Program
			Submissions, Forms, ContactsCDER Direct NextGen Collaboration Portal
			Submissions, Forms, ContactsCDER Direct NextGen Collaboration Portal FAQs
			Submissions, Forms, ContactsElectronic Regulatory Submission and Review
			Submissions, Forms, ContactsFDA Forms
			Submissions, Forms, ContactsForms and Submission Requirements
			Submissions, Forms, ContactsOffice of New Drugs Contacts
			Submissions, Forms, ContactsReorganization of the Office of New Drugs
			Submissions, Forms, ContactsAddresses for regulatory submissions
			Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA)Electronic Common Technical Document (eCTD)
			Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA)FDA IND, NDA, ANDA, or Drug Master File Binders
			Submissions, Forms, Contacts; Investigational New Drug Application (IND); New Drug Review, New Drug Application (NDA); Generic Drugs, Abbreviated New Drug Application (ANDA); Drug Master FilesCDER SBIA Learn: Respository of Training Resources and Recordings
			Training ResourcesCDERLearn Training and Education
			Training ResourcesStay Informed with FDA Interactive Media
			Training ResourcesVideo and Transcript: FDA/CDER's Small Business and Industry Assistance (SBIA)
			Training ResourcesFDA User Fee Programs
			User Fees

                                                                                  Content current as of:
      01/10/2024
              
              
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