Search for Pharmaceutical Quality Documents

Container Closure System and Component Changes: Glass Vials and Stoppers Guidance 7/24/2024 NDA, ANDA, BLA, CGMP, Container Closure/Packaging, Lifecycle Management, Specification and Testing Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers Guidance 7/23/2024 BLA (biologics); Drug Product; CGMP; Lifecycle Management; Specification and Testing MAPP 5015.14 Prioritization of Solicited DMF Amendments Associated With ANDAs or PASs not Concurrently Under Assessment MAPP 5/3/2024 DMF (drug master files), ANDA (generic drugs) Platform Technology Designation Program for Drug Development Guidance 5/29/2024 Multi-Disciplinary Reformulating 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, ICH 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance 1/17/2017 CGMP; Administrative/Procedural; Container Closure/Packaging; Drug Product Abuse-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 Emergency Advanced Manufacturing Technologies Designation Program Guidance 12/13/2023 Emerging/Advanced Tech, Drug product, Drug Substance/API, Administrative/Procedural Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance 9/29/2017 Emerging/Advanced Technology Allowable 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/API Analytical Procedures and Methods Validation for Drugs and Biologics Guidance 7/27/2015 ANDA (generic drugs); NDA (new drugs); BLA (biologics); Lifecyle Management ANDAs: Impurities in Drug Products Guidance 11/29/2010 Drug Product; ANDA (generic drugs); ICH; Specification and Testing ANDAs: Impurities in Drug Substances Guidance 7/15/2009 ANDA (generic drugs); Drug Substance/API ANDAs: Pharmaceutical Solid Polymorphism: Chemistry, Manufacturing, and Controls Information Guidance 7/9/2007 Drug Substance/API; Drug Product; ANDA (generic drugs); Specification and Testing ANDAs: 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/API ANDAs: Stability Testing of Drug Substances and Products Guidance 6/20/2013 ANDA (generic drugs); Specification and Testing; Drug Substance/API; Drug Product ANDAs: 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 Product ANDAs 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 Product Assessment 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 Emergency Benefit-Risk Considerations for Product Quality Assessments Guidance 5/9/2022 NDA (new drugs); BLA (biologics); ANDA (generic drugs); Drug Product; Drug Substance/API; Lifecycle Management Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance 12/8/2020 Administrative/Procedural; Drug Product; Container Closure/Packaging Bioavailability 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 Distribution Bioavailability 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 Distribution Botanical Drug Development Guidance 12/29/2016 IND (investigational new drugs); ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug Product Cannabis 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 Testing CDER’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/Procedural CGMP for Phase 1 Investigational Drugs Guidance 7/14/2008 IND (investigational new drugs); CGMP The “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 Management Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Guidance 04/1/1996 BLA (biologics); CGMP; Specification and Testing Determining 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/Procedural Development 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 Testing Development of New Stereoisomeric Drugs Guidance 5/1/1992 Drug Product; Drug Substance/API; CGMP Dissolution 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; Biopharmaceutics Dissolution 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; ICH Drug 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); administrative Drug 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 Distribution Elemental Impurities in Drug Products Guidance 8/8/2018 ICH; Compendial Standards; NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Compendial Standards Environmental Assessment of Human Drug and Biologics Applications Guidance 7/27/1998 NDA (new drugs); IND (investigational new drugs); BLA (biologics); Drug Product Environmental 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 Product Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers Guidance 6/3/2016 IND (investigational new drugs); Drug Product; Administrative/Procedural Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron Guidance 6/9/1997 Specification and Testing; Storage and Distribution Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products Guidance 7/29/2020 CGMP; Specification and Testing; Storage and Distribution Extended 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 Standards Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles Guidance 4/24/2019 Public Health Emergency; CGMP; Drug Product; Storage and Distribution Facility Readiness: Goal Date Decisions Under GDUFA Guidance 6/18/2024 ANDA (generic drugs); Drug Substance/API; Drug Product; CGMP; Administrative/Procedural FDA Oversight of PET Drug Products Questions and Answers Guidance 12/3/2012 Drug Product; ICH; CGMP; Administrative/Procedural; Specification and Testing; Container Closure/Packaging Field Alert Report Submission: Questions and Answers Guidance 7/22/2021 NDA (new drugs); ANDA (generic drugs); Specification and Testing; Drug Product Fixed-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/Procedural Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP Guidance 1/11/2006 CGMP; Administrative/Procedural Format and Content for the CMC Section of an Annual Report Guidance 9/1/1994 NDA (new drugs); ANDA (generic drugs); Lifecycle Management; emerging/advanced tech General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products Guidance 11/21/17 ANDA (generic drugs); Specification and Testing; Drug Product Glass 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 Distribution Harmonizing 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 Testing Heparin 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; ICH ICH 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/Procedural Immunogenicity Assessment for Therapeutic Protein Products Guidance 8/14/2014 BLA (biologics); IND (investigational new drugs); Drug Product; Container Closure/Packaging; Storage and Distribution Immunogenicity Testing of Therapeutic Protein Products—Developing and Validating Assays for Anti-Drug Antibody Detection Guidance 2/19/2019 IND (investigational new drugs); CGMP Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance 2/18/2016 ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Lifecycle Management Incorporation 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 Management IND 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 Product INDs 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); CGMP Inspection 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 Management Interim 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 Distribution Interim 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 Distribution Interpretation 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 Management Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Guidance 5/16/2022 Specification and Testing; CGMP; Administrative/Procedural Investigational 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 Distribution Investigational 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 Distribution Labeling for Biosimilar Products Guidance 7/18/2018 BLA (biologics); Administrative/Procedural Limiting 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 ingredients Liposome 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; Biopharmaceutics Media Fills for Validation of Aseptic Preparations for Positron Emission Tomography Guidance 4/11/2012 CGMP; Specification and Testing; Microbiology Metered 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; Microbiology Microbiological 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/Procedural Mixing, 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 Ingredient Monoclonal 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; Microbiology Naming 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/Procedural Nasal Spray and Inhalation Solution, Suspension, and Spray Drug Products–Chemistry, Manufacturing, and Controls Documentation Guidance 7/5/2002 Specification and Testing; Drug Product; Compendial Standards NDAs: Impurities in Drug Substances Guidance 2/1/2000 NDA (new drugs); Drug Substance/API; Specification and Testing; ICH; Compendial Standards Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination Guidance 4/17/2013 CGMP; Drug Substance/API; ICH; Storage and Distribution Non-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 Testing Nonproprietary Naming of Biological Products Guidance 1/17/2017 BLA (biologics); Administrative/Procedural Oral 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 Standards PAC-ATLS: Postapproval Changes—Analytical Testing Laboratory Sites Guidance 4/28/1998 NDA (new drugs); ANDA (generic drugs); Lifecycle Management PAT—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; ICH PET Drug Products—Current Good Manufacturing Practice (CGMP) Guidance 12/10/2009 CGMP; Drug Product Pharmaceutical Components at Risk for Melamine Contamination Guidance 8/6/2009 Drug Substance/API; Drug Product; CGMP; Specification and Testing; Excipient/Inactive Ingredient Planning 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; CGMP Points 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 Distribution Postapproval Changes to Drug Substances Guidance 9/11/2018 ANDA (generic drugs); NDA (new drugs); DMF (drug master files); Drug Substance/API; Lifecycle Management Potassium Iodide Tablets—Shelf Life Extension Guidance 3/08/2004 Public Health Emergency; Drug Product; Specification and Testing; Storage and Distribution; Biopharmaceutics; Compendial Standards Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens Guidance 3/1/2023 IND (investigational new drugs); BLA (biologics); Specification and Testing Preparation 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/API Pyrogen and Endotoxins Testing: Questions and Answers Guidance 6/1/2012 CGMP; Specification and Testing; Microbiology; Compendial Standards Q&A on CGMP Requirements Guidance 9/15/2022 Container Closure/Packaging; CGMP; Storage and Distribution; Administrative/Procedural; Specification and Testing Q1A(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; Biopharmaceutics Q1B 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/Packaging Q1C 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/Packaging Q1D 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/Packaging Q1E 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; Biopharmaceutics Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance 9/16/2021 ICH; Specification and Testing Q3A 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; CGMP Q3B(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; CGMP Q3C Impurities: Residual Solvents Guidance 12/24/1997 ICH; Specification and Testing, NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient Q3C—Tables and List Guidance 8/1/2018 ICH; NDA (new drugs); ANDA (generic drugs); Drug Substance/API; Drug Product; Excipient/Inactive Ingredient Q3D(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 Ingredient Q4B 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 Testing Q4B Annex 11: Capillary Electrophoresis General Chapter Guidance 9/3/2010 NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing Q4B Annex 12: Analytical Sieving General Chapter Guidance 9/2/2010 NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing Q4B 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 Testing Q4B Annex 14: Bacterial Endotoxins Test General Chapter Guidance 10/23/2013 NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing Q4B 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 Testing Q4B 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; CGMP Q4B 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 Product Q4B 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 Product Q4B 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/API Q4B 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 Product Q4B 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 Testing Q4B 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; CGMP Q4B Annex 8(R1): Sterility Test General Chapter Guidance 12/22/2009 NDA (new drugs); ANDA (generic drugs); BLA (biologics); ICH; Compendial Standards; Specification and Testing Q4B 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 Product Q4B 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 Testing Q4B 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 Testing Q5A(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; CGMP Q5B 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/Packaging Q5D 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 Product Q5E 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; CGMP Q6A 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; Microbiology Q6B 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; CGMP Q7 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; Microbiology Q8(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; CGMP Q9(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; CGMP Q10 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 Distribution Q11 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; CGMP Q11 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/Procedural Q12 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; CGMP Quality Attribute Considerations for Chewable Tablets Guidance 8/21/2018 Drug Product; Administrative/Procedural; NDA (new drugs); ANDA (generic drugs); IND (investigational new drugs); Compendial Standards Quality 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 Distribution Quality 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 Distribution Questions 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; Biopharmaceutics Referencing Approved Drug Products in ANDA Submissions Guidance 10/27/2020 ANDA (generic drugs); Specification and Testing; Drug Product Regulatory Classification of Pharmaceutical Co-Crystals Guidance 2/15/2018 NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Substance/API Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities Guidance 10/25/2023 NDA (new drugs); ANDA (generic drugs); BLA (biologics); CGMP Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities Guidance 1/13/2017 Drug Product; CGMP; Container Closure/Packaging; Compounding; Storage and Distribution Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Guidance 10/29/2021 BLA (biologics); NDA (new drugs); Drug Product; Drug Substance/API Reports 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/Procedural Residual 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 Management Residual Solvents in Drug Products Marketed in the United States Guidance 11/25/2009 NDA (new drugs); ANDA (generic drugs); Drug Product; Compendial Standards; ICH Review 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/Procedural Reviewer Guidance, Validation of Chromatographic Methods Guidance 11/1/1994 Drug Substance/API; Drug Product; Lifecycle Management Risk 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 Distribution Scientific 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 Distribution Selection 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/Procedural Size of Beads in Drug Products Labeled for Sprinkle Guidance 5/16/2012 ANDA (generic drugs); NDA (new drugs); BLA (biologics); Drug Product Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules Guidance 10/3/2022 ANDA (generic drugs); Drug Product Statistical 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/Packaging Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice Guidance 10/4/2004 CGMP; Microbiology Submission 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 Product Submission 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 Product SUPAC: Manufacturing Equipment Addendum Guidance 12/2/2014 NDA (new drugs); ANDA (generic drugs); Lifecycle Management SUPAC-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 Ingredient SUPAC-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 Ingredient SUPAC-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 Ingredient SUPAC-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 Ingredient Tablet Scoring: Nomenclature, Labeling, and Data for Evaluation Guidance 3/13/2013 ANDA (generic drugs); Drug Product; Lifecycle Management; Specification and Testing Technical 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 Testing Testing of Glycerin for Diethylene Glycol Guidance 5/8/2023 Excipient/Inactive Ingredient; CGMP; Compendial Standards The 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 Testing The 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 Management Transdermal and Topical Delivery Systems – Product Development and Quality Considerations Guidance 11/21/2019 NDA (new drugs); ANDA (generic drugs); Drug Product; Specification and Testing Type 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/Procedural Use 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; Biopharmaceutics Using the Inactive Ingredient Database Guidance 7/11/2019 NDA (new drugs); ANDA (generic drugs); Administrative/Procedural; Drug Product; Excipient/Inactive Ingredient Preapproval 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 Distribution Inspections 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 managament Sterile 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/Packaging Drug 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 Standards Radioactive 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/Packaging Compressed Medical Gases (7356.002E) Compliance Program 3/15/2015 CGMP Active 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; ICH Surveillance 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 managament Positron 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 managament Drug 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 Standards Drug 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 Standards Postapproval 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 Distribution MAPP 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 Ingredient MAPP 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 Ingredient MAPP 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/Packaging MAPP 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 Management MAPP 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/Procedural MAPP 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; Microbiology MAPP 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/Packaging MAPP 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/Procedural MAPP 5015.8 Acceptance Criteria for Residual Solvents MAPP 12/1/2022 Drug Substance/API; Drug Product; Specification and Testing; Excipient/Inactive Ingredient; ICH MAPP 5018.2 NDA Classification Codes MAPP 12/08/2022 Drug Product; IND (investigational new drugs); NDA (new drugs); Drug Substance/API; Administrative/Procedural MAPP 5016.6 Change in Hard Gelatin Capsule Supplier MAPP 2/21/2023 NDA (new drugs); ANDA (generic drugs); Lifecycle Management; Compendial Standards MAPP 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 Management MAPP 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 Emergency MAPP 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/Procedural MAPP 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 Product MAPP 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 Distribution MAPP 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 Standards MAPP 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/Packaging MAPP 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 tech MAPP 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; CGMP Changes to an Approved NDA or ANDA  Guidance 4/8/2004 ANDA (generic drugs); NDA (new drugs); Lifecycle Management; CGMP; Container Closure/Pacakging Changes to an Approved NDA or ANDA: Questions and Answers Guidance 1/1/2001 NDA (new drugs); ANDA (generic drugs); Lifecycle Management Changes 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 Management Changes to Disposable Manufacturing Materials: Questions and Answers Guidance 7/29/2022 BLA (biologics); Lifecycle Management; CGMP; NDA (new drugs); ANDA (generic drugs); Container Closure/Packing Child-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 Testing CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports  Guidance 12/9/2021 BLA (biologics); Administrative/Procedural CMC 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 Product Comparability 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 Testing Completeness Assessments for Type II API DMFs Under GDUFA Guidance 10/11/2017 ANDA (generic drugs); Drug Substance/API; Administrative/Procedural Considerations in Demonstrating Interchangeability With a Reference Product Guidance 5/10/2019 BLA (biologics); Lifecycle Management; Container Closure/Packaging; Specification and Testing Container 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 Product Container 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); CGMP Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance 11/23/2016 CGMP; Storage and Distribution; Administrative/Procedural; Specification and Testing Control of Nitrosamine Impurities in Human Drugs Guidance 9/5/2024 NDA, ANDA, BLA, IND, DMF, Drug Substance/API, Drug Product, CGMP, Lifecycle Management, Specification and Testing, Biopharmaceutics Cooperative Manufacturing Arrangements for Licensed Biologics Guidance 2/24/2021 BLA (biologics); CGMP; Container Closure/Packaging; Specification and Testing; Lifecycle Management; Storage and Distribution COVID-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 Product Current Good Manufacturing Practice for Medical Gases  Guidance 6/29/2017 CGMP; Specification and Testing; Administrative/Procedural Current Good Manufacturing Practice Requirements for Combination Products Guidance 1/11/2017 Drug Substance/API; Drug Product; CGMP; Container Closure/Packaging; Specification and Testing; Storage and Distribution; Microbiology Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance 1/22/2020 CGMP; Compounding; Drug Substance/API; Drug Product; Specification and Testing; Microbiology Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance 12/13/2018 CGMP; Compounding; Drug Substance/API; Drug Product; Specification and Testing; Microbiology Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Guidance 4/1/1996 BLA (biologics); CGMP; Specification and Testing Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance 9/22/2023 NDA (new drugs); ANDA (generics); BLA (biologics); CGMP; public health emergency Quality Considerations for Topical Ophthalmic Drug Products Guidance 12/28/2023 NDA (new drugs); ANDA (generics); BLA (biologics); Drug Product; Specification and Testing; Container Closure/Packaging; Compendial Standards MAPP 5021.5 Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests MAPP 1/15/2024 ANDA (generics); Administrative/Procedural; CGMP MAPP 5016.8 Using Four-Part Harmony in Quality-Related Assessment Communications MAPP 9/22/2023 Administrative/Procedural; Lifecycle Management; IND (investigational new drugs); NDA (new drugs); ANDA (generics); BLA (biologics); DMF (drug master files) MAPP 5017.8 Responsibilities for the Assessment of In Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube MAPP 9/5/2023 Drug Product; IND (investigational new drugs); NDA (new drugs); ANDA (generics); Specification and Testing; Biopharmaceutics Good ANDA Submission Practices Guidance 1/26/2022 ANDA (generics); Drug Product; Drug Substance/API; Biopharmaceutics; Microbiology; CGMP; Administrative/Procedural; DMF (drug master files); Specification and Testing MAPP 5241.3 Rev. 1 Good Abbreviated New Drug Application Assessment Practices MAPP 10/6/2023 ANDA (generics); Administrative/Procedural; Drug Product

Source