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                Pharmaceutical Quality Resources

Pharmaceutical Quality Resources

                        Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program
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          Search for Pharmaceutical Quality DocumentsPharmaceutical Quality Resources Search for Pharmaceutical Quality Documents
  
  	
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    PrintThe table below lists pharmaceutical quality-related guidances, MAPPs, and compliance programs. Use the type, topic, and search options separately or combined to narrow your results.

Use type, topic, and search to find resources

Type Compliance ProgramGuidanceMAPP


Topic Administrative/ProceduralANDA (generic drugs)BiopharmaceuticsBLA (biologics)CGMPCompendial StandardsCompoundingContainer Closure/PackagingDMF (drug master files)Drug ProductDrug Substance/APIEmerging/Advanced TechExcipient/Inactive IngredientICHIND (investigational new drugs)Lifecycle ManagementMicrobiologyNDA (new drugs)Public Health EmergencySpecification and TestingStorage and Distribution

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Title
			Type
			Date
			TopicReformulating Drug Products That Contain Carbomers Manufactured With Benzene
			Guidance
			12/28/2023
			NDA (new drugs), ANDA (generic drugs), DMF (drug master files), Drug Product, CGMP, Compendial Standards, Lifecycle Management, Specification and Testing, Excipient/Inactive Ingredient, Biopharmaceutics, ICH2016 Medical Gas Container-Closure Rule Questions and Answers
			Guidance
			1/17/2017
			CGMP; Administrative/Procedural; Container Closure/Packaging; Drug ProductAbuse-Deterrent Opioids — Evaluation and Labeling
			Guidance
			4/2/2015
			NDA (new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Storage and Distribution; Excipient/Inactive Ingredient; ICH; Public Health EmergencyAdvanced Manufacturing Technologies Designation Program
			Guidance
			12/13/2023
			Emerging/Advanced Tech, Drug product, Drug Substance/API, Administrative/ProceduralAdvancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
			Guidance
			9/29/2017
			Emerging/Advanced TechnologyAllowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
			Guidance
			6/25/2015
			ANDA (generic drugs); NDA (new drugs); BLA (biologics)Alternate Source of the Active Pharmaceutical Ingredient in Pending ANDAs
			Guidance
			12/1/2000
			ANDA (generic drugs); Drug Substance/APIAnalytical Procedures and Methods Validation for Drugs and Biologics
			Guidance
			7/27/2015
			ANDA (generic drugs); NDA (new drugs); BLA (biologics); Lifecyle ManagementANDAs: Impurities in Drug Products
			Guidance
			11/29/2010
			Drug Product; ANDA (generic drugs); ICH; Specification and TestingANDAs: Impurities in Drug Substances
			Guidance
			7/15/2009
			ANDA (generic drugs); Drug Substance/APIANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information
			Guidance
			7/9/2007
			Drug Substance/API; Drug Product; ANDA (generic drugs); Specification and TestingANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
			Guidance
			12/2/2022
			ANDA (generic drugs); DMF (drug master files); Administrative/Procedural; Drug Product; Drug Substance/APIANDAs: Stability Testing of Drug Substances and Products
			Guidance
			6/20/2013
			ANDA (generic drugs); Specification and Testing; Drug Substance/API; Drug ProductANDAs: Stability Testing of Drug Substances and Products, Questions and Answers
			Guidance
			5/15/2014
			ANDA (generic drugs); Specification and Testing; Container Closure/Packaging; Drug Substance/API; Drug ProductANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin
			Guidance
			5/19/2021
			ANDA (generic drugs); NDA (new drugs); Specification and Testing; Drug ProductAssessment of Abuse Potential of Drugs
			Guidance
			1/18/2017
			NDA (new drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Storage and Distribution; ICH; Administrative/Procedural; Public Health EmergencyBenefit-Risk Considerations for Product Quality Assessments
			Guidance
			5/9/2022
			NDA (new drugs); BLA (biologics); ANDA (generic drugs); Drug Product; Drug Substance/API; Lifecycle ManagementBest Practices in Developing Proprietary Names for Human Prescription Drug Products
			Guidance
			12/8/2020
			Administrative/Procedural; Drug Product; Container Closure/PackagingBioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action
			Guidance
			4/3/2003
			Specification and Testing; Biopharmaceutics; Lifecycle Management; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); Compendial Standards; Drug Product; Storage and DistributionBioavailability and Bioequivalence Studies Submitted in NDAs or INDs — General Considerations
			Guidance
			3/18/2014
			IND (investigational new drugs); NDA (new drugs); Drug Product; Lifecycle Management; Drug Substance/API; Biopharmaceutics; Storage and DistributionBotanical Drug Development
			Guidance
			12/29/2016
			IND (investigational new drugs); ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug ProductCannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
			Guidance
			1/23/2023
			Drug Substance/API; IND (investigational new drugs); NDA (new drugs); Specification and TestingCDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
			Guidance
			7/26/2023
			IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics); Compendial Standards; Administrative/ProceduralCGMP for Phase 1 Investigational Drugs
			Guidance
			7/14/2008
			IND (investigational new drugs); CGMPThe "Deemed to be a License" Provision of the BPCI Act: Questions and Answers
			Guidance
			3/4/2020
			NDA (new drugs); BLA (biologics); Administrative/Procedural; Lifecycle ManagementDemonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
			Guidance
			04/1/1996
			BLA (biologics); CGMP; Specification and TestingDetermining Whether to Submit an ANDA or a 505(b)(2) Application
			Guidance
			5/10/2019
			NDA (new drugs); ANDA (generic drugs); Drug Product; Container Closure/Packaging; Excipient/Inactive Ingredient; Administrative/ProceduralDevelopment and Submission of Near Infrared Analytical Procedures
			Guidance
			8/6/2021
			NDA (new drugs); ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; ICH; CGMP; Lifecycle Management; Administrative/Procedural; Specification and TestingDevelopment of New Stereoisomeric Drugs
			Guidance
			5/1/1992
			Drug Product; Drug Substance/API; CGMPDissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
			Guidance
			8/9/2018
			Specification and Testing; ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); Drug Substance/API; ICH; BiopharmaceuticsDissolution Testing of Immediate Release Solid Oral Dosage Forms
			Guidance
			8/25/1997
			Lifecycle Management; Drug Product; Biopharmaceutics; NDA (new drugs); ANDA (generic drugs); Excipient/Inactive Ingredient; Compendial Standards; ICHDrug Master Files
			Guidance
			11/15/2019
			Drug Substance/API; Administrative/Procedural; DMF (drug master files)Drug Master Files for Bulk Antibiotic Drug Substances
			Guidance
			11/29/1999
			DMF (drug master files); administrativeDrug Products, Including Biological Products, that Contain Nanomaterials
			Guidance
			4/21/2022
			Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); IND (investigational new drugs); emerging/advanced tech; Specification and Testing; Drug Substance/API; Excipient/Inactive Ingredient; CGMP; Lifecycle Management; Storage and DistributionElemental Impurities in Drug Products
			Guidance
			8/8/2018
			ICH; Compendial Standards; NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Compendial StandardsEnvironmental Assessment of Human Drug and Biologics Applications
			Guidance
			7/27/1998
			NDA (new drugs); IND (investigational new drugs); BLA (biologics); Drug ProductEnvironmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity
			Guidance
			3/4/2016
			IND (investigational new drugs); ANDA (generic drugs); BLA (biologics); Administrative/Procedural; Drug ProductExpanded Access to Investigational Drugs for Treatment Use—Questions and Answers
			Guidance
			6/3/2016
			IND (investigational new drugs); Drug Product; Administrative/ProceduralExpiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron
			Guidance
			6/9/1997
			Specification and Testing; Storage and DistributionExpiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products
			Guidance
			7/29/2020
			CGMP; Specification and Testing; Storage and DistributionExtended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations
			Guidance
			9/1/1997
			Lifecycle Management; NDA (new drugs); ANDA (generic drugs); Specification and Testing; Drug Product; Excipient/Inactive Ingredient; Compendial StandardsExtending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles
			Guidance
			4/24/2019
			Public Health Emergency; CGMP; Drug Product; Storage and DistributionFacility Readiness: Goal Date Decisions Under GDUFA
			Guidance
			10/3/2022
			ANDA (generic drugs); CGMP; Administrative/ProceduralFDA Oversight of PET Drug Products Questions and Answers
			Guidance
			12/3/2012
			Drug Product; ICH; CGMP; Administrative/Procedural; Specification and Testing; Container Closure/PackagingField Alert Report Submission: Questions and Answers
			Guidance
			7/22/2021
			NDA (new drugs); ANDA (generic drugs); Specification and Testing; Drug ProductFixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR
			Guidance
			8/2/2023
			Drug Product; Biopharmaceutics; Specification and Testing; Lifecycle Management; Administrative/ProceduralFormal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP
			Guidance
			1/11/2006
			CGMP; Administrative/ProceduralFormat and Content for the CMC Section of an Annual Report
			Guidance
			9/1/1994
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; emerging/advanced techGeneral Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
			Guidance
			11/21/17
			ANDA (generic drugs); Specification and Testing; Drug ProductGlass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4
			Guidance
			3/31/2013
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Product; Container Closure/Packaging; Storage and DistributionHarmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process
			Guidance
			7/10/2019
			DMF (drug master files); Compendial Standards; Drug Product; Specification and TestingHeparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
			Guidance
			6/25/2013
			CGMP; Drug Substance/API; Drug Product; Compendial Standards; Specification and Testing; ICHICH Q12: Implementation Considerations for FDA-Regulated Products
			Guidance
			5/20/2021
			ICH; Lifecycle Management; CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers
			Guidance
			10/22/2019
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); Administrative/ProceduralImmunogenicity Assessment for Therapeutic Protein Products
			Guidance
			8/14/2014
			BLA (biologics); IND (investigational new drugs); Drug Product; Container Closure/Packaging; Storage and DistributionImmunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection
			Guidance
			2/19/2019
			IND (investigational new drugs); CGMPImmunogenicity-Related Considerations for Low Molecular Weight Heparin
			Guidance
			2/18/2016
			ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Lifecycle ManagementIncorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting
			Guidance
			10/11/2011
			NDA (new drugs); ANDA (generic drugs); Drug Product; Lifecycle ManagementIND Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Clinical Recommendations
			Guidance
			12/8/2021
			IND (investigational new drugs); Drug ProductINDs for Phase 2 and Phase 3 Studies: Chemistry, Manufacturing, and Controls Information
			Guidance
			5/20/2003
			Drug Substance/API; Drug Product; IND (investigational new drugs); CGMPInspection of Injectable Products for Visible Particulates
			Guidance
			12/16/2021
			Drug Product; CGMP; Compendial Standards; Container Closure/Packaging; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Specification and Testing; Lifecycle ManagementInterim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
			Guidance
			6/10/2016
			BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Compounding; Storage and DistributionInterim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act
			Guidance
			6/10/2016
			BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/Packaging; Compounding; Storage and DistributionInterpretation of the "Deemed to be a License" Provision of the Biologics Price Competition and Innovation Act of 2009
			Guidance
			12/12/2018
			Administrative/Procedural; Lifecycle ManagementInvestigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
			Guidance
			5/16/2022
			Specification and Testing; CGMP; Administrative/ProceduralInvestigational New Drug Applications for Positron Emission Tomography (PET) Drugs
			Guidance
			12/3/2012
			IND (investigational new drugs); Specification and Testing; Drug Product; NDA (new drugs); CGMP; ANDA (generic drugs); Specification and Testing; Compendial Standards; DMF; Container Closure/Packaging; Drug Substance/API; Storage and DistributionInvestigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
			Guidance
			5/15/2015
			IND (investigational new drugs); Drug Product; Administrative/Procedural; Specification and Testing; Container Closure/Packaging; Storage and DistributionLabeling for Biosimilar Products
			Guidance
			7/18/2018
			BLA (biologics); Administrative/ProceduralLimiting the Use of Certain Phthalates as Excipients in CDER-Regulated Products
			Guidance
			12/6/2012
			IND (investigational new drugs); NDA (new drugs); BLA (biologics); ANDA (generic drugs); Drug Product; excipients/inactive ingredientsLiposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation
			Guidance
			4/5/2018
			NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; BiopharmaceuticsMedia Fills for Validation of Aseptic Preparations for Positron Emission Tomography
			Guidance
			4/11/2012
			CGMP; Specification and Testing; MicrobiologyMetered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations
			Guidance
			4/19/2018
			Drug Product; Container Closure/Packaging; Storage and Distribution; Specification and Testing; Compendial Standards; MicrobiologyMicrobiological Quality Considerations in Non-sterile Drug Manufacturing
			Guidance
			9/29/2021
			CGMP; Microbiology; NDA (new drugs); ANDA (generic drugs); Drug Product; Drug Substance/API; Lifecycle Management; Compendial Standards; Specification and Testing; Container Closure/Packaging; Storage and Distribution; Administrative/ProceduralMixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application
			Guidance
			1/18/2018
			BLA (biologics); Drug Substance/API; Drug Product; CGMP; Container Closure/Packaging; Compounding; Storage and Distribution; Excipient/Inactive IngredientMonoclonal Antibodies Used as Reagents in Drug Manufacturing
			Guidance
			3/1/2001
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; MicrobiologyNaming of Drug Products Containing Salt Drug Substances
			Guidance
			6/17/2015
			Drug Product; Drug Substance/API; Compendial Standards; NDA (new drugs); ANDA (generic drugs); Administrative/ProceduralNasal Spray and Inhalation Solution, Suspension, and Spray Drug Products--Chemistry, Manufacturing, and Controls Documentation
			Guidance
			7/5/2002
			Specification and Testing; Drug Product; Compendial StandardsNDAs: Impurities in Drug Substances
			Guidance
			2/1/2000
			NDA (new drugs); Drug Substance/API; Specification and Testing; ICH; Compendial StandardsNon-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
			Guidance
			4/17/2013
			CGMP; Drug Substance/API; ICH; Storage and DistributionNon-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination
			Guidance
			6/24/2022
			CGMP; Drug Product; Drug Substance/API; Lifecycle Management; Specification and TestingNonproprietary Naming of Biological Products
			Guidance
			1/17/2017
			BLA (biologics); Administrative/ProceduralOral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations
			Guidance
			6/2/2021
			Specification and Testing; Drug Product; NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs)Orally Disintegrating Tablets
			Guidance
			12/16/2008
			ANDA (generic drugs); NDA (new drugs); Drug Product; Specification and Testing; Compendial StandardsPAC-ATLS: Postapproval Changes—Analytical Testing Laboratory Sites
			Guidance
			4/28/1998
			NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementPAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance
			Guidance
			10/4/2004
			CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)PET Drug Applications—Content and Format for NDAs and ANDAs
			Guidance
			8/31/2011
			Administrative/Procedural; Drug Product; Specification and Testing; Compendial Standards; CGMP; ICHPET Drug Products—Current Good Manufacturing Practice (CGMP)
			Guidance
			12/10/2009
			CGMP; Drug ProductPharmaceutical Components at Risk for Melamine Contamination
			Guidance
			8/6/2009
			Drug Substance/API; Drug Product; CGMP; Specification and Testing; Excipient/Inactive IngredientPlanning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
			Guidance
			3/15/2011
			Public Health Emergency; Administrative/Procedural; Drug Product; CGMPPoints to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
			Guidance
			2/28/1997
			CGMP; Microbiology, Drug Product; Specification and Testing; Container Closure/Packaging; Storage and DistributionPostapproval Changes to Drug Substances
			Guidance
			9/11/2018
			ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Drug Substance/API; Lifecycle ManagementPotassium Iodide Tablets—Shelf Life Extension
			Guidance
			3/08/2004
			Public Health Emergency; Drug Product; Specification and Testing; Storage and Distribution; Biopharmaceutics; Compendial StandardsPotency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens
			Guidance
			3/1/2023
			IND (investigational new drugs); BLA (biologics); Specification and TestingPreparation of Investigational New Drug Products (Human and Animal)
			Guidance
			11/1/1992
			CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Process Validation: General Principles and Practices
			Guidance
			1/25/2011
			CGMP; ICH; Specification and Testing; Drug Product; Drug Substance/APIPyrogen and Endotoxins Testing: Questions and Answers
			Guidance
			6/1/2012
			CGMP; Specification and Testing; Microbiology; Compendial StandardsQ&A on CGMP Requirements
			Guidance
			9/15/2022
			Container Closure/Packaging; CGMP; Storage and Distribution; Administrative/Procedural; Specification and TestingQ1A(R2) Stability Testing of New Drug Substances and Products
			Guidance
			11/21/2003
			ANDA (generic drugs); ICH; Specification and Testing; NDA (new drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/Packaging; Microbiology; BiopharmaceuticsQ1B Photostability Testing of New Drug Substances and Products
			Guidance
			3/7/1996
			ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Container Closure/PackagingQ1C Stability Testing for New Dosage Forms
			Guidance
			5/9/1997
			ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/PackagingQ1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products
			Guidance
			1/16/2003
			ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Container Closure/PackagingQ1E Evaluation of Stability Data
			Guidance
			6/8/2004
			ICH; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Storage and Distribution; Specification and Testing; Container Closure/Packaging; BiopharmaceuticsQ2(R1) Validation of Analytical Procedures: Text and Methodology
			Guidance
			9/16/2021
			ICH; Specification and TestingQ3A Impurities in New Drug Substances
			Guidance
			6/6/2008
			ICH; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); Specification and Testing; Storage and Distribution; CGMPQ3B(R2) Impurities in New Drug Products
			Guidance
			8/4/2006
			ICH; NDA (new drugs); ANDA (generic drugs); Drug Product; Excipient/Inactive Ingredient; Container Closure/Packaging; Specification and Testing; Storage and Distribution; CGMPQ3C Impurities: Residual Solvents
			Guidance
			12/24/1997
			ICH; Specification and Testing, NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientQ3C—Tables and List
			Guidance
			8/1/2018
			ICH; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientQ3D(R2) Elemental Impurities
			Guidance
			9/14/2022
			ICH; NDA (new drugs); ANDA (generic drugs); Drug Product; Specification and Testing; CGMP; Container Closure/Packaging; Excipient/Inactive IngredientQ4B Annex 10(R1): Polyacrylamide Gel Electrophoresis General Chapter
			Guidance
			9/2/2010
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 11: Capillary Electrophoresis General Chapter
			Guidance
			9/3/2010
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 12: Analytical Sieving General Chapter
			Guidance
			9/2/2010
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 13: Bulk Density and Tapped Density of Powders General Chapter
			Guidance
			5/28/2013
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 14: Bacterial Endotoxins Test General Chapter
			Guidance
			10/23/2013
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 2(R1): Test for Extractable Volume of Parenteral Preparations General Chapter
			Guidance
			9/18/2017
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Drug Product; Specification and TestingQ4B Annex 3(R1): Test for Particulate Contamination: Subvisible Particles General Chapter
			Guidance
			1/9/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Drug Product; Specification and Testing; CGMPQ4B Annex 4A(R1): Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests General Chapter
			Guidance
			4/8/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug ProductQ4B Annex 4B(R1): Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter
			Guidance
			4/8/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug ProductQ4B Annex 4C(R1): Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use General Chapter
			Guidance
			4/8/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Microbiology; Drug Product; Drug Substance/APIQ4B Annex 5(R1): Disintegration Test General Chapter
			Guidance
			12/23/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Drug ProductQ4B Annex 6: Uniformity of Dosage Units General Chapter
			Guidance
			6/16/2014
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 7(R2): Dissolution Test General Chapter
			Guidance
			6/24/2011
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; CGMPQ4B Annex 8(R1): Sterility Test General Chapter
			Guidance
			12/22/2009
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Annex 9(R1): Tablet Friability General Chapter
			Guidance
			4/5/2010
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing; Drug ProductQ4B Annex I(R1): Residue on Ignition/Sulphated Ash General Chapter
			Guidance
			2/21/2008
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions
			Guidance
			2/20/2008
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and TestingQ5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin
			Guidance
			11/10/2022
			ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; CGMPQ5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products
			Guidance
			2/23/1996
			ICH; Specification and Testing; BLA (biologics)Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
			Guidance
			7/1/1996
			ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient; Storage and Distribution; Container Closure/PackagingQ5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products
			Guidance
			9/21/1998
			ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug ProductQ5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
			Guidance
			6/30/2005
			ICH; BLA (biologics); Drug Substance/API; Drug Product; Lifecycle Management; Specification and Testing; CGMPQ6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
			Guidance
			12/29/2000
			ICH; Specification and Testing; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Compendial Standards; CGMP; MicrobiologyQ6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
			Guidance
			8/18/1999
			ICH; Specification and Testing; BLA (biologics); Drug Substance/API; Drug Product; Compendial Standards; CGMPQ7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
			Guidance
			9/30/2016
			ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Substance/API; CGMP; Container Closure/Packaging; Specification and Testing; Storage and Distribution; MicrobiologyQ8(R2) Pharmaceutical Development
			Guidance
			11/20/2009
			ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Administrative/Procedural; Drug Product; Drug Substance/API; Excipient/Inactive Ingredient; Container Closure/Packaging; Microbiology; Specification and Testing; CGMPQ9(R1) Quality Risk Management
			Guidance
			5/3/2023
			ICH; Drug Product; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Excipient/Inactive Ingredient; Container Closure/Packaging; Storage and Distribution; Specification and Testing; CGMPQ10 Pharmaceutical Quality System
			Guidance
			4/8/2009
			ICH; CGMP; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Storage and DistributionQ11 Development and Manufacture of Drug Substances
			Guidance
			11/20/2012
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Drug Substance/API; Administrative/Procedural; Specification and Testing; Microbiology; CGMPQ11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities)—Questions and Answers
			Guidance
			2/26/2018
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Drug Substance/API; CGMP; Specification and Testing; Administrative/ProceduralQ12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
			Guidance
			5/11/2021
			Lifecycle Management; ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Q13 Continuous Manufacturing of Drug Substances and Drug Products
			Guidance
			3/1/2023
			ICH; emerging/advanced tech; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Lifecycle Management; CGMPQuality Attribute Considerations for Chewable Tablets
			Guidance
			8/21/2018
			Drug Product; Administrative/Procedural; NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); Compendial StandardsQuality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product
			Guidance
			4/30/2015
			IND (investigational new drugs); BLA (biologics); ICH; Specification and Testing; Drug Product; Excipient/Inactive Ingredient; Drug Substance/API; Storage and DistributionQuality Systems Approach to Pharmaceutical CGMP Regulations
			Guidance
			10/2/2006
			ICH; CGMP; Drug Substance/API; Drug Product; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Storage and DistributionQuestions and Answers on Quality Related Controlled Correspondence
			Guidance
			9/20/2021
			ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; Microbiology; Container Closure/Packaging; Compendial Standards; Specification and Testing; BiopharmaceuticsReferencing Approved Drug Products in ANDA Submissions
			Guidance
			10/27/2020
			ANDA (generic drugs); Specification and Testing; Drug ProductRegulatory Classification of Pharmaceutical Co-Crystals
			Guidance
			2/15/2018
			NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Substance/APIRemote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities
			Guidance
			10/25/2023
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMPRepackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities
			Guidance
			1/13/2017
			Drug Product; CGMP; Container Closure/Packaging; Compounding; Storage and DistributionReporting Amount of Listed Drugs and Biological Products Technical Conformance Guide
			Guidance
			10/29/2021
			BLA (biologics); NDA (new drugs); Drug Product; Drug Substance/APIReports on the Status of Postmarketing Study Commitments — Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997
			Guidance
			2/16/2006
			Specification and Testing; Lifecycle Management; Administrative/ProceduralResidual Drug in Transdermal and Related Drug Delivery Systems
			Guidance
			8/17/2011
			IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); Drug Product; Lifecycle ManagementResidual Solvents in Drug Products Marketed in the United States
			Guidance
			11/25/2009
			NDA (new drugs); ANDA (generic drugs); Drug Product; Compendial Standards; ICHReview of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
			Guidance
			10/3/2022
			DMF (drug master files); ANDA (generic drugs); Drug Substance/API; Administrative/ProceduralReviewer Guidance, Validation of Chromatographic Methods
			Guidance
			11/1/1994
			Drug Substance/API; Drug Product; Lifecycle ManagementRisk Management Plans To Mitigate the Potential for Drug Shortages
			Guidance
			5/19/2022
			CGMP; Drug Product; Drug Substance/API; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Lifecycle Management; Public Health Emergency; Storage and DistributionScientific Considerations in Demonstrating Biosimilarity to a Reference Product
			Guidance
			4/28/2015
			BLA (biologics); Drug Product; Specification and Testing; Lifecycle Management; Drug Substance/API; Storage and DistributionSelection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use
			Guidance
			10/3/2018
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); Container Closure/Packaging; Drug Product; Administrative/ProceduralSize of Beads in Drug Products Labeled for Sprinkle
			Guidance
			5/16/2012
			ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug ProductSize, Shape, and Other Physical Attributes of Generic Tablets and Capsules
			Guidance
			10/3/2022
			ANDA (generic drugs); Drug ProductStatistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999
			Guidance
			4/11/2003
			Container Closure/PackagingSterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice
			Guidance
			10/4/2004
			CGMP; MicrobiologySubmission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products
			Guidance
			11/1/1994
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP; Storage and Distribution; Specification and Testing; Microbiology; Container Closure/Packaging; Drug ProductSubmission of Documentation in Applications for Parametric Release of Human and Veterinary Drug Products Terminally Sterilized by Moist Heat Processes
			Guidance
			2/26/2010
			CGMP; Storage and Distribution; Specification and Testing; Microbiology; Container Closure/Packaging; Drug ProductSUPAC: Manufacturing Equipment Addendum
			Guidance
			12/2/2014
			NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementSUPAC-IR Questions and Answers about SUPAC-IR Guidance
			Guidance
			2/18/1997
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation
			Guidance
			11/1/1995
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-MR: Modified Release Solid Oral Dosage Forms Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation
			Guidance
			10/6/1997
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientSUPAC-SS: Nonsterile Semisolid Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation
			Guidance
			5/1/1997
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Biopharmaceutics; Specification and Testing; Excipient/Inactive IngredientTablet Scoring: Nomenclature, Labeling, and Data for Evaluation
			Guidance
			3/13/2013
			ANDA (generic drugs); Drug Product; Lifecycle Management; Specification and TestingTechnical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
			Guidance
			6/7/2013
			ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); BLA (biologics); Drug Product; Specification and TestingTesting of Glycerin for Diethylene Glycol
			Guidance
			5/8/2023
			Excipient/Inactive Ingredient; CGMP; Compendial StandardsThe Use of Mechanical Calibration of Dissolution Apparatus 1 and 2—Current Good Manufacturing Practice (CGMP)
			Guidance
			1/27/2010
			Biopharmaceutics; Compendial Standards; CGMP; Drug Product; Specification and TestingThe Use of Physiologically Based Pharmacokinetic Analyses—Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls
			Guidance
			9/30/2020
			Biopharmaceutics; ANDA (generic drugs); NDA (new drugs); IND (investigational new drugs); Drug Product; Lifecycle ManagementTransdermal and Topical Delivery Systems - Product Development and Quality Considerations
			Guidance
			11/21/2019
			NDA (new drugs); ANDA (generic drugs); Drug Product; Specification and TestingType V DMFs for CDER-Led Combination Products Using Device Constituent Parts With Electronics or Software
			Guidance
			10/29/2019
			DMF (drug master files); Drug Product; Administrative/ProceduralUse of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments
			Guidance
			7/25/2018
			Drug Product; Compendial Standards; Specification and Testing; BiopharmaceuticsUsing the Inactive Ingredient Database
			Guidance
			7/11/2019
			NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Excipient/Inactive IngredientPreapproval Inspections (7346.832)
			Compliance Program
			10/17/2022
			CGMP; Drug Product; Drug Substance/API; ICH; DMF (drug master files); ANDA (generic drugs); NDA (new drugs); Specification and Testing; Microbiology; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/Packaging; lifecycle managament; Storage and DistributionInspections of CDER-Led or CDRH-Led Combination Products (7356.000)
			Compliance Program
			6/4/2020
			CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Drug Manufacturing Inspections (7356.002)
			Compliance Program
			10/17/2022
			CGMP; Drug Product; Drug Substance/API; ICH; ANDA (generic drugs); NDA (new drugs); Specification and Testing; Microbiology; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/Packaging; Storage and Distribution; lifecycle managamentSterile Drug Process Inspections (7356.002A)
			Compliance Program
			9/11/2015
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP; Microbiology; Drug Substance/API; Drug Product; Container Closure/PackagingDrug Repackagers and Relabelers (7356.002B)
			Compliance Program
			9/11/2015
			CGMP; Container Closure/Packaging; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Specification and Testing; Compendial StandardsRadioactive Drugs (7356.002C)
			Compliance Program
			9/11/2015
			CGMP; NDA (new drugs); ANDA (generic drugs); BLA (biologics); Specification and Testing; Microbiology; Drug Product; Excipient/Inactive Ingredient; Compendial Standards; Container Closure/PackagingCompressed Medical Gases (7356.002E)
			Compliance Program
			3/15/2015
			CGMPActive Pharmaceutical Ingredient (API) Process Inspection (7356.002F)
			Compliance Program
			9/11/2015
			CGMP; Drug Substance/API; ICH; DMF (drug master files); ANDA (generic drugs); NDA (new drugs); Container Closure/Packaging; Specification and Testing; ICHSurveillance Inspections of Protein Drug Substance Manufacturers (7356.002M)
			Compliance Program
			10/1/2021
			CGMP; Drug Substance/API; ICH; BLA (biologics); Container Closure/Packaging; Specification and Testing; Microbiology; Excipient/Inactive Ingredient; lifecycle managamentPositron Emission Tomography (PET) CGMP Drug Process and Pre-Approval Inspections/Investigations (7356.002P)
			Compliance Program
			9/11/2015
			Drug Product; Specificaton and Testing; CGMP; Drug Substance/API; IND (investigational new drugs); ANDA (generic drugs); NDA (new drugs); Container Closure/Packaging; Microbiology; Compendial Standards; Storage and Distribution; lifecycle managamentDrug Quality Sampling and Testing (DQST)—Human Drugs (7356.008)
			Compliance Program
			9/11/2015
			Drug Product; Specification and Testing; CGMP; Drug Substance/API; ANDA (generic drugs); NDA (new drugs); Microbiology; Compendial StandardsDrug Quality Reporting System (DQRS) (MedWatch Reports); NDA Field Alert Reports (FARs) (7356.021)
			Compliance Program
			9/11/2015
			Drug Product; Specification and Testing; Drug Substance/API; ANDA (generic drugs); NDA (new drugs); Microbiology; Compendial StandardsPostapproval Inspections (7356.843)
			Compliance Program
			3/13/2023
			NDA (new drugs); ANDA (generic drugs); DMF (drug master files); Drug Product; Drug Substance/API; CGMP; Lifecycle Management; Specification and Testing; Storage and DistributionMAPP 5021.2 Evaluating Color Additives and Flavors Intended for Oral Drug Products Submitted or Referenced in INDs and NDAs
			MAPP
			6/21/2023
			NDA (new drugs); IND (investigational new drugs); DMF (drug master files); Drug Product; Excipient/Inactive IngredientMAPP 5016.3 Rev. 1 Responsibility for the Quality Assessment of Products Containing Peptide or Protein Drug Substances
			MAPP
			6/21/2023
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Excipient/Inactive IngredientMAPP 5021.1 Rev. 1 Naming of Drug Products Containing Salt Drug Substances
			MAPP
			12/2/2022
			NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Container Closure/PackagingMAPP 5001.1 Drug Product Distribution After a Complete Response Action to a Changes Being Effected Supplement
			MAPP
			11/23/2022
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Substance/API; Drug Product; Lifecycle ManagementMAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)
			MAPP
			12/7/2022
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Product; Container Closure/Packaging; Specification and Testing; Storage and Distribution; Drug Substance/API; Microbiology; ICH; Administrative/ProceduralMAPP 5210.9 Rev. 1 Review of Botanical Drug Products
			MAPP
			12/30/2016
			NDA (new drugs); IND (investigational new drugs); Drug Substance/API; Drug Product; Lifecycle Management; Specification and Testing; Biopharmaceutics; MicrobiologyMAPP 5019.1 Rev. 1 Allowable Excess Volume/Content in Injectable Drug and Biological Products
			MAPP
			1/28/2022
			NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); BLA (biologics); Drug Product; Container Closure/PackagingMAPP 5017.1 Rev. 1 Office of Biotechnology Products and Office of Pharmaceutical Manufacturing Assessment, Interactions on BLA Assessments
			MAPP
			12/2/2022
			BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Specification and Testing; Administrative/ProceduralMAPP 5015.8 Acceptance Criteria for Residual Solvents
			MAPP
			12/1/2022
			Drug Substance/API; Drug Product; Specification and Testing; Excipient/Inactive Ingredient; ICHMAPP 5018.2 NDA Classification Codes
			MAPP
			12/08/2022
			Drug Product; IND (investigational new drugs); NDA (new drugs); Drug Substance/API; Administrative/ProceduralMAPP 5016.6 Change in Hard Gelatin Capsule Supplier
			MAPP
			2/21/2023
			NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Compendial StandardsMAPP 5016.1 Applying ICH Q8(R2), Q9, and Q10 Principles to Chemistry, Manufacturing, and Controls Review
			MAPP
			5/18/2016
			ICH; NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient; Lifecycle ManagementMAPP 5310.3 Rev. 2 Requests for Expedited Review of New Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and Controls Changes
			MAPP
			4/8/2021
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Product; Lifecycle Management; Public Health EmergencyMAPP 5017.2 Rev. 1 Establishing Impurity Acceptance Criteria As Part of Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance
			MAPP
			5/1/2020
			IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics); Drug Product; Specification and Testing; ICH; Compendial StandardsMAPP 5015.5 Rev. 1 CMC Reviews of Type III DMFs for Packaging Materials
			MAPP
			12/9/2022
			DMF (drug master files); Compendial Standards; Lifecycle Management; Drug Substance/API; Drug Product; Container Closure/Packaging; Specification and Testing; NDA (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs)MAPP 5022.0 CDER Liaisons to Official Compendia and Standards Development Organizations – Selection Process, Roles, and Responsibilities
			MAPP
			12/7/2022
			Compendial Standards; Administrative/ProceduralMAPP 5015.7 Rev. 1 Environmental Assessments and Claims of Categorical Exclusion
			MAPP
			11/23/2022
			Lifecycle Management; Drug Substance/API; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics)MAPP 5014.1 Rev. 1 Understanding CDER's Risk-Based Site Selection Model
			MAPP
			6/26/2023
			CGMP; Drug Substance/API; Drug ProductMAPP 5015.6 Rev. 1 Review of Grouped Product Quality Supplements
			MAPP
			12/9/2022
			Lifecycle Management; NDA (new drugs); ANDA (generic drugs); BLA (biologics)MAPP 5040.1 Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)
			MAPP
			12/7/2022
			Microbiology; Specification and Testing; ANDA (generic drugs); BLA (biologics); ICH; Container Closure/Packaging; Lifecyle Management; NDA (new drugs); Drug Substance/API; Storage and DistributionMAPP 5310.7 Rev 1 Acceptability of Standards from Alternative Compendia (BP/EP/JP)
			MAPP
			12/8/2022
			Excipient/Inactive Ingredient; Drug Substance/API; Drug Product; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); Specification and Testing; Compendial StandardsMAPP 5017.4 Quality Center for Drug Evaluation and Research Biopharmaceutics Council
			MAPP
			5/16/2019
			Excipient/Inactive Ingredient; Drug Product; Biopharmaceutics; IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs)MAPP 5019.2 Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products
			MAPP
			6/6/2022
			NDA (new drugs); BLA (biologics); Drug Product; ANDA (generic drugs); IND (investigational new drugs); Container Closure/PackagingMAPP 5015.12 Process for Evaluating Emerging Technologies Related to Quality
			MAPP
			12/1/2022
			IND (investigational new drugs); NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); emerging/advanced techMAPP 5015.13 Quality Assessment for Products in Expedited Programs
			MAPP
			12/7/2022
			NDA (new drugs); BLA (biologics); IND (investigational new drugs); Drug Product; Drug Substance/API; Public Health Emergency; Specification and Testing; Storage and Distribution; Container Closure/Packaging; CGMPChanges to an Approved NDA or ANDA
			Guidance
			4/8/2004
			ANDA (generic drugs); NDA (new drugs); Lifecycle Management; CGMP; Container Closure/PacakgingChanges to an Approved NDA or ANDA: Questions and Answers
			Guidance
			1/1/2001
			NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementChanges to an Approved NDA or ANDA; Specifications—Use of Enforcement Discretion for Compendial Changes
			Guidance
			11/22/2004
			NDA (new drugs); ANDA (generic drugs); Lifecycle ManagementChanges to Disposable Manufacturing Materials: Questions and Answers
			Guidance
			7/29/2022
			BLA (biologics); Lifecycle Management; CGMP; NDA (new drugs); ANDA (generic drugs); Container Closure/PackingChild-Resistant Packaging Statements in Drug Product Labeling
			Guidance
			8/13/2019
			Container Closure/Packaging; Drug Product; Administrative/Procedural; NDA (new drugs); ANDA (generic drugs); BLA (biologics)Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
			Guidance
			12/29/2016
			BLA (biologics); Specification and TestingCMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
			Guidance
			12/9/2021
			BLA (biologics); Administrative/ProceduralCMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
			Guidance
			3/5/2014
			ANDA (generic drugs); NDA (new drugs); Container Closure/Packaging; Lifecycle Management; Specification and Testing; Drug ProductComparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA
			Guidance
			10/13/2022
			NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); Lifecycle Management; Drug Product; Drug Substance/API; CGMP; Container Closure/Packaging; Specification and TestingCompleteness Assessments for Type II API DMFs Under GDUFA
			Guidance
			10/11/2017
			ANDA (generic drugs); Drug Substance/API; Administrative/ProceduralConsiderations in Demonstrating Interchangeability With a Reference Product
			Guidance
			5/10/2019
			BLA (biologics); Lifecycle Management; Container Closure/Packaging; Specification and TestingContainer and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
			Guidance
			2/25/2009
			Container Closure/Packaging; Specification and Testing; CGMP; Drug ProductContainer Closure Systems for Packaging Human Drugs and Biologics
			Guidance
			7/7/1999
			Drug Product; Drug Substance/API; CGMP; Container Closure/Packaging; Drug Product; DMF (drug master files)Container Closure Systems for Packaging Human Drugs and Biologics: Questions and Answers
			Guidance
			5/1/2002
			Drug Product; Container Closure/Packaging; BLA (biologics); CGMPContract Manufacturing Arrangements for Drugs: Quality Agreements
			Guidance
			11/23/2016
			CGMP; Storage and Distribution; Administrative/Procedural; Specification and TestingControl of Nitrosamine Impurities in Human Drugs
			Guidance
			2/24/2021
			Drug Substance/API; Drug Product; Specification and Testing; ICH; Lifecycle ManagementCooperative Manufacturing Arrangements for Licensed Biologics
			Guidance
			2/24/2021
			BLA (biologics); CGMP; Container Closure/Packaging; Specification and Testing; Lifecycle Management; Storage and DistributionCOVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers
			Guidance
			3/4/2021
			Public Health Emergency; Container Closure/Packaging; ANDA (generic drugs); BLA (biologics); NDA (new drugs); Specification and Testing; Compendial Standards; Drug ProductCurrent Good Manufacturing Practice for Medical Gases
			Guidance
			6/29/2017
			CGMP; Specification and Testing; Administrative/ProceduralCurrent Good Manufacturing Practice Requirements for Combination Products
			Guidance
			1/11/2017
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			Guidance
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			Guidance
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			CGMP; Compounding; Drug Substance/API; Drug Product; Specification and Testing; MicrobiologyDemonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products
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			4/1/1996
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			Guidance
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			Guidance
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			MAPP
			1/15/2024
			ANDA (generics); Administrative/Procedural; CGMPMAPP 5016.8 Using Four-Part Harmony in Quality-Related Assessment Communications
			MAPP
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			Drug Product; IND (investigational new drugs); NDA (new drugs); ANDA (generics); Specification and Testing; BiopharmaceuticsGood ANDA Submission Practices
			Guidance
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			ANDA (generics); Drug Product; Drug Substance/API; Biopharmaceutics; Microbiology; CGMP; Administrative/Procedural; DMF (drug master files); Specification and TestingMAPP 5241.3 Rev. 1 Good Abbreviated New Drug Application Assessment Practices
			MAPP
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			ANDA (generics); Administrative/Procedural; Drug Product

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      01/11/2024
              
              
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