Search for Pharmaceutical Quality Documents
The 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.
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| Title | Type | Date | Topic |
|---|---|---|---|
| MAPP 5018.3 Implementation of Established Conditions as Described in ICH Q12 | MAPP | 10/16/2024 | NDA (new drugs); ANDA (generic drugs); BLA (biologics); DMF (drug master files); Drug Substance/API; Drug Product; Lifecycle Management; ICH; Administrative/Procedural |
| Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA | Guidance | 10/17/2024 | ANDA (Generic Drugs); DMF (Drug Master Files); Drug Substance/API |
| Container Closure System and Component Changes: Glass Vials and Stoppers | Guidance | 7/24/2024 | NDA (new drugs); ANDA (generic drugs); BLA (biologics); 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 (new drugs); ANDA (generic drugs); BLA (biologics); IND (investigational new drugs); DMF (drug master files); 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 |