| ICH-Quality |
Q9(R1) Quality Risk Management |
Draft |
6/14/2022 |
| Import |
Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide |
Final |
5/25/2022 |
| Clinical/Antimicrobial |
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers (Revision 1) |
Draft |
5/24/2022 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Risk Management Plans to Mitigate the Potential for Drug Shortages |
Draft |
5/19/2022 |
| Drug Safety |
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors |
Final |
5/18/2022 |
| Generics; User Fees |
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 |
Final |
5/17/2022 |
| Pharmaceutical Quality/Manufacturing Standards (CGMP) |
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision |
Final |
5/16/2022 |
| Pharmaceutical Quality - CMC |
Benefit-Risk Considerations for Product Quality Assessments |
Draft |
5/9/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies |
Draft |
5/4/2022 |
| ICH-Safety |
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility |
Final |
4/29/2022 |
| ICH-Efficacy |
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility |
Final |
4/29/2022 |
| ICH-Safety |
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility |
Final |
4/29/2022 |
| ICH-Safety |
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products |
Final |
4/29/2022 |
| Electronic/Submission |
Electronic Submission of IND Safety Reports Technical Conformance Guide: Guidance for Industry |
Final |
4/29/2022 |
| Clinical/Medical |
Crohn’s Disease: Developing Drugs for Treatment |
Draft |
4/28/2022 |
| Clinical/Medical |
Ulcerative Colitis: Developing Drugs for Treatment |
Draft |
4/28/2022 |
| Electronic Submissions |
Providing Submissions in Electronic Format—Postmarketing Safety Reports |
Final |
4/27/2022 |
| Clinical/Medical |
Celiac Disease: Developing Drugs for Adjunctive Treatment to a Gluten-Free Diet |
Draft |
4/15/2022 |
| Clinical Pharmacology |
Bioavailability Studies Submitted in NDAs or INDs – General Considerations |
Final |
4/15/2022 |
| Generics |
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use |
Draft |
4/13/2022 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs |
Final |
4/11/2022 |
| International Council for Harmonisation - Efficacy |
E8(R1) General Considerations for Clinical Studies |
Final |
4/8/2022 |
| Pharmacology / Toxicology |
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers |
Draft |
4/7/2022 |
| ICH-Multidisciplinary |
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES |
Draft |
4/6/2022 |
| Clinical/Antimicrobial |
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment |
Final |
4/6/2022 |
| Combination Products |
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry |
Final |
3/22/2022 |
| Procedural |
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs |
Rev. Draft |
03/09/2022 |
| Procedural |
Pre-Launch Activities Importation Requests (PLAIR) |
Final |
03/01/2022 |
| Procedural |
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry |
Final |
0301/2022 |
| Procedural |
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics |
Final |
03/01/2022 |
| Clinical / Medical |
Development of Non-Opioid Analgesics for Acute Pain |
Draft |
02/09/2022 |
| COVID-19 |
COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels |
Final |
02/08/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry |
Draft |
02/07/2022 |
| COVID-19 |
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic |
Final |
02/04/2022 |
| Procedural |
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) |
Final |
02/03/2022 |
| Clinical Pharmacology |
Population Pharmacokinetics |
Final |
02/03/2022 |
| Clinical / Medical |
Assessment of Pressor Effects of Drugs Guidance for Industry |
Draft |
02/03/2022 |
| Labeling |
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format |
Draft |
02/03/2022 |
| Procedural |
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
Draft |
2/01/2022 |
| Generics |
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry |
Draft |
1/25/2022 |
|
Technical Specifications Document
|
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). |
Final |
1/21/2022 |
| Electronic Submissions |
Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs |
Final |
4/11/2022 |
| International Council for Harmonisation - Efficacy |
E8(R1) General Considerations for Clinical Studies |
Final |
4/8/2022 |
| Pharmacology / Toxicology |
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers |
Draft |
4/7/2022 |
| ICH-Multidisciplinary |
M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES |
Draft |
4/6/2022 |
| Clinical/Antimicrobial |
Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment |
Final |
4/6/2022 |
| Combination Products |
Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry |
Final |
3/22/2022 |
| Procedural |
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs |
Rev. Draft |
03/09/2022 |
| Procedural |
Pre-Launch Activities Importation Requests (PLAIR) |
Final |
03/01/2022 |
| Procedural |
Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics Guidance for Industry |
Final |
0301/2022 |
| Procedural |
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics |
Final |
03/01/2022 |
| Clinical / Medical |
Development of Non-Opioid Analgesics for Acute Pain |
Draft |
02/09/2022 |
| COVID-19 |
COVID-19 Public Health Emergency Policy on COVID-19-Related Sanitation Tunnels |
Final |
02/08/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry |
Draft |
02/07/2022 |
| COVID-19 |
Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic |
Final |
02/04/2022 |
| Procedural |
FDA’s guidance on uniform national policy (Section 585 of the FD&C Act) |
Final |
02/03/2022 |
| Clinical Pharmacology |
Population Pharmacokinetics |
Final |
02/03/2022 |
| Clinical / Medical |
Assessment of Pressor Effects of Drugs Guidance for Industry |
Draft |
02/03/2022 |
| Labeling |
Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product Labeling--Content and Format |
Draft |
02/03/2022 |
| Procedural |
Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs |
Draft |
2/01/2022 |
| Generics |
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry |
Draft |
1/25/2022 |
|
Technical Specifications Document
|
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH). |
Final |
9/30/2021 |
| ICH-Quality |
Q3B(R) Impurities in New Drug Products (Revision 3) |
Final |
9/29/2021 |
| Biologics |
Benefit-Risk Assessment for New Drug and Biological Products |
Draft |
9/29/2021 |
| Pharmaceutical Quality/ Microbiology Pharmaceutical Quality/ Manufacturing Standards (CGMP) |
Microbiological Quality Considerations in Non-Sterile Drug Manufacturing |
Draft |
9/29/2021 |
| Drug Safety |
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices |
Draft |
9/29/2021 |
| Real World Data/Real World Evidence |
Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products |
Draft |
9/28/2021 |
| Clinical/Antimicrobial |
Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex: Developing Drugs for Treatment |
Draft |
9/2820/21 |
| Pharmaceutical Quality |
Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry |
Draft |
9/20/2021 |
| Biosimilars |
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 3) |
Draft |
9/17/2021 |
| Biosimilars |
Questions and Answers on Biosimilar Development and the BPCI Act |
Final |
9/17/2021 |
| ICH - Quality |
Q2(R1) Validation of Analytical Procedures: Text and Methodology Guidance for Industry |
Final |
9/16/2021 |
| ICH - Safety |
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS |
Draft |
9/13/2021 |
| Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
9/8/2021 |
| Technical Specifications Document |
Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of Noncirrhotic Nonalcoholic Steatohepatitis (NASH) |
Final |
8/31/2021 |
| Covid-19 |
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency |
Rev. Final |
8/30/2021 |
| Generics |
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application |
Rev. Draft |
8/20/2021 |
| Pharmaceutical Quality - CMC |
Development and Submission of Near Infrared Analytical Procedures |
Final |
8/6/2021 |
| Clinical/Medical |
Nonmetastatic Castration-Resistant Prostate Cancer: Considerations for Metastasis-Free Survival Endpoint in Clinical Trials |
Final |
8/6/2021 |
| Clinical/Antimicrobial |
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry |
Draft |
7/28/2021 |
| Pharmaceutical Quality - CMC |
Field Alert Report Submission: Questions and Answers Guidance for Industry |
Final |
7/22/2021 |
| Clinical/Medical |
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications |
Draft |
7/1/2021 |
| Electronic Submissions |
Providing Regulatory Submissions in Alternate Electronic Format |
Final |
7/1/2021 |
| Drug Safety |
Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry |
Draft |
6/25/2021 |
| Procedural |
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
| Procedural |
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification |
Final |
6/3/2021 |
| Procedural |
Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act |
Final |
6/3/2021 |
| Labeling |
Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers |
Final |
6/3/2021 |
| Pharmaceutical Quality - CMC and Labeling |
Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry |
Draft |
6/2/2021 |
| Pharmaceutical Quality - CMC |
Bispecific Antibody Development Programs Guidance for Industry |
Final |
5/24/2021 |
| ICH-Quality |
ICH Q12: Implementation Considerations for FDA-Regulated Products Guidance for Industry |
draft |
5/20/2021 |
| Biostatistics |
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Guidance for Industry |
draft |
5/20/2021 |
| Generic Drugs |
ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin Guidance for Industry |
draft |
5/19/2021 |
| Procedural |
Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions Statement of Investigator (Form FDA 1572) (Revision 1) |
Draft |
5/19/2021 |
| COVID-19 |
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry |
Final |
5/17/2021 |
| COVID-19- |
COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention |
Final |
5/17/2021 |
| ICH- |
M9 Biopharmaceutics Classification System-Based Biowaivers |
Final |
5/11/2021 |
| ICH - |
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials |
Final |
5/11/2021 |
| ICH |
Q3D(R2) – Guideline for Elemental Impurities-Investigators |
Final |
5/11/2021 |
| ICH |
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals |
Final |
5/11/2021 |
| ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry |
Final |
5/11/2021 |
| ICH |
Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex |
Final |
5/11/2021 |
| Pharm / Tox |
S11 Nonclinical Safety Testing In Support of Development of Pediatric Pharmaceuticals |
Final |
5/11/2021 |
| Procedural |
Qualified Infectious Disease Product Designation Questions and Answers |
Draft |
5/11/2021 |
| Pharm / Tox |
Nonclinical Testing of Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases Guidance for Sponsor-Investigators |
Draft |
4/26/2021 |
| Covid-19 |
Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry |
Final |
4/14/2021 |
| Covid-19 |
Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry |
Final |
4/5/2021 |
