| Pharmaceutical Quality / CMC |
Bispecific Antibody Development Programs Guidance for Industry (PDF - 90 KB) |
Draft guidance |
4/18/19 |
| Pharmaceutical Quality / CMC Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Quality Considerations for Continuous Manufacturing Guidance for Industry (PDF - 197 KB) |
Draft guidance |
2/26/19 |
| Pharmaceutical Quality/CMC |
Immunogenicity Testing of Therapeutic Protein Products —Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (PDF - 372 KB) |
Final Guidance |
1/23/19 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 127 KB) |
Final Guidance |
12/12/18 |
| Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act (PDF - 476KB) |
Draft guidance |
12/10/18 |
| Pharmaceutical Quality/CMC |
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 (PDF - 167KB) |
Final Guidance |
10/02/18 |
| Pharmaceutical Quality/CMC. |
Postapproval Changes to Drug Substances Guidance for Industry (PDF - 393KB) |
Draft guidance |
09/10/18 |
| Pharmaceutical Quality/CMC |
Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 169KB) |
Final Guidance |
08/20/18 |
| Biopharmaceuticals |
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances Guidance for Industry (PDF - 103KB) |
Final Guidance |
08/08/18 |
| Pharmaceutical Quality/CMC |
Elemental Impurities in Drug Products Guidance for Industry (PDF - 92KB) |
Final Guidance |
08/07/18 |
| Pharmaceutical Quality/CMC |
Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments (PDF - 410KB) |
Draft Guidance |
7/24/2018 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) and Pharmaceutical Quality/CMC |
Field Alert Report Submission: Questions and Answers Guidance for Industry (PDF - 123KB) |
Draft Guidance |
7/18/2018 |
| International Council for Harmonisation - Quality |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Core Guideline Guidance for Industry (PDF - 451KB) |
Draft Guidance |
5/30/2018 |
| International Council for Harmonisation - Quality |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex (PDF - 223KB) |
Draft Guidance |
5/30/2018 |
| International Council for Harmonisation - Quality |
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Questions and Answers Guidance for Industry (PDF - 218KB) |
Final Guidance |
4/19/18 |
| Pharmaceutical Quality/CMC |
Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products--Quality Considerations (PDF - 449KB) |
Draft Guidance, Revised |
4/18/18 |
| Pharmaceutical Quality/CMC |
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 120KB) |
Final Guidance |
4/4/18 |
| International Council for Harmonisation - Quality |
Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) (PDF - 843KB) |
Final Guidance |
2/23/18 |
| Pharmaceutical Quality/CMC |
Regulatory Classification of Pharmaceutical Co-Crystals (PDF - 87KB) |
Revised Final Guidance |
02/14/18 |
| Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (PDF - 556KB) |
Final Guidance |
01/18/18 |
| Biopharmaceutics |
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. Guidance for Industry (PDF - 161KB) |
Final Guidance |
12/22/17 |
| Pharmaceutical Quality / CMC |
Drug Products, Including Biological Products, that Contain Nanomaterials - Guidance for Industry (PDF - 235KB) |
Draft Guidance |
12/15/17 |
| Labeling |
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry (PDF - 136KB) |
Draft Guidance |
12/12/17 |
| Pharmaceutical Quality/CMC / Generics |
ANDAs: Pre-Submission of Facility Information Related to Prioritized Generic Drug Applications (Pre-Submission Facility Correspondence) Guidance for Industry (PDF - 151KB) |
Draft Guidance |
11/03/17 |
| Generics/User Fees/ Pharmaceutical Quality/CMC |
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry (PDF - 379KB) |
Final Guidance |
10/04/17 |
| Pharmaceutical Quality/CMC |
Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization Guidance for Industry (PDF - 71KB) |
Final Guidance |
09/28/17 |
| Pharmaceutical Quality/CMC |
CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports (PDF - 93KB) |
Draft Guidance |
08/08/17 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products (PDF - 72KB) |
Draft Guidance |
08/08/17 |
| Labeling |
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry (PDF - 96KB) |
Draft Guidance |
08/02/17 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Current Good Manufacturing Practice for Medical Gases (PDF - 219KB) |
Draft Guidance |
06/28/17 |
| Procedural |
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles (PDF - 226KB) |
Draft Guidance |
04/24/17 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic Format – Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (PDF - 112KB) |
Final Guidance |
04/07/17 |
| Compounding/Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities (PDF - 646KB) |
Final Guidance |
01/12/17 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Current Good Manufacturing Practice Requirements for Combination Products |
Final Guidance |
01/10/17 |
| Pharmaceutical Quality/CMC |
Botanical Drug Development: Guidance for Industry (PDF - 221KB) |
Final Guidance |
12/28/16 |
| Pharmaceutical Quality/CMC and Pharmaceutical Quality/CGMP |
Submission of Quality Metrics Data Guidance for Industry (PDF - 340KB) |
Draft Guidance |
11/23/16 |
| Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) |
Final Guidance |
11/22/16 |
| Pharmaceutical Quality - CMC |
Regulatory Classification of Pharmaceutical Co-Crystals- Draft (PDF - 82KB) |
Draft Guidance |
08/16/16 |
| Pharmaceutical Quality/CMC |
Elemental Impurities in Drug Products (PDF - 100KB) |
Draft Guidance |
06/30/16 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Technical Specifications Document: "Quality Metrics Technical Conformance Guide, Version 1.0“ has published (PDF - 114KB) |
Draft Guidance |
06/24/16 |
| Pharmaceutical Quality/CMC |
Quality Attribute Considerations for Chewable Tablets Guidance for Industry (PDF - 121KB) |
Draft Guidance |
06/16/16 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry (PDF - 120KB) |
Draft Guidance |
04/14/16 |
| Pharmaceutical Quality/CMC |
Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products (PDF - 230KB) |
Draft Guidance |
04/22/16 |
| Pharmaceutical Quality/CMC |
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry (PDF - 200KB) |
Draft Guidance |
04/19/16 |
| Pharmaceutical Quality/CMC |
Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry (PDF - 136KB) |
Final Guidance |
02/18/16 |
| Pharmaceutical Quality/CMC |
Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation (PDF - 146KB) |
Draft Guidance |
10/29/15 |
| Pharmaceutical Quality/CMC |
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 (PDF - 113KB) |
Draft Guidance |
10/21/15 |
| Biopharmaceuticals |
Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs Guidance for Industry (PDF - 87KB) |
Draft Guidance |
07/31/15 |
| Pharmaceutical Quality/CMC |
Analytical Procedures and Methods Validation for Drugs and Biologics (PDF - 134KB) |
Final Guidance |
07/24/15 |
| Pharmaceutical Quality/CMC |
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products (PDF - 77KB) |
Final Guidance |
06/24/15 |
| Pharmaceutical Quality/CMC |
Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules (PDF - 89KB) |
Final Guidance |
06/18/15 |
| Labeling |
Naming of Drug Products Containing Salt Drug Substances (PDF - 210KB) |
Final Guidance |
06/16/15 |
| Pharmaceutical Quality/CMC |
Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products Guidance for Industry (PDF - 165KB) |
Draft Guidance |
05/29/15 |
| Pharmaceutical Quality/CMC |
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity (PDF - 69KB) |
Final Guidance |
03/04/16 |
| Pharmaceutical Quality/CMC |
Development and Submission of Near Infrared Analytical Procedures (PDF - 176KB) |
Draft Guidance |
03/30/15 |
