| Electronic Submissions |
Providing Over-the-Counter Monograph Submissions in Electronic Format |
Draft |
9/27/2022 |
| Administrative/Procedural |
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry |
Final |
9/22/2022 |
| Administrative/Procedural |
How To Obtain a Covered Product Authorization |
Draft |
9/21/2022 |
| Labeling |
Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products |
Draft |
9/8/2022 |
| Labeling |
Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products |
Draft |
9/8/2022 |
Real World Data/Real World Evidence (RWD/RWE)
Administrative/Procedural |
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products |
Final |
9/8/2022 |
| |
E11A Pediatric Extrapolation |
Draft |
8/26/2022 |
| ICH-Multidisciplinary |
M12 Drug Interaction Studies |
Draft |
8/26/2022 |
| ICH-Quality |
Q14 Analytical Procedure Development |
Draft |
8/26/2022 |
| ICH-Quality |
Q2(R2) Validation of Analytical ProceduresQ14 Analytical Procedure Development |
Draft |
8/26/2022 |
| ICH-Efficacy, ICH-Safety |
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential--Questions and Answers |
Final |
8/26/2022 |
| Administrative / Procedural |
Charging for Investigational Drugs Under an IND: Questions and Answers |
Draft |
8/23/2022 |
| ICH-Safety |
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products |
Final |
8/15/2022 |
| Electronic Submissions |
Biosearch Monitoring Technical Conformance Guide |
Final |
8/15/2022 |
| Generics |
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies |
Draft |
8/2/2022 |
| Pharmaceutical Quality |
Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry |
Final |
7/29/2022 |
| Labeling |
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” |
Draft |
7/20/2022 |
| Generics |
Evaluation of Therapeutic Equivalence |
Draft |
7/20/2022 |
| Labeling |
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format |
Final |
7/15/2022 |
| Administrative/Procedural |
Identifying Trading Partners Under the Drug Supply Chain Security Act |
Draft |
7/5/2022 |
| Administrative/Procedural |
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments |
Draft |
6/29/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics |
Draft |
6/27/2022 |
| Clinical Pharmacology |
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations |
Final |
6/24/2022 |
| Administrative / Procedural |
Considerations for Rescinding Breakthrough Therapy Designation Guidance for Industry |
Draft |
6/24/2022 |
| Pharmaceutical Quality/Current Good Manufacturing Practice (CGMP) |
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination |
Draft - Revised Final |
6/24/2022 |
| 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 |
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations |
Final |
6/24/2022 |
| Administrative / Procedural |
Considerations for Rescinding Breakthrough Therapy Designation Guidance for Industry |
Draft |
6/24/2022 |
| Pharmaceutical Quality/Current Good Manufacturing Practice (CGMP) |
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination |
Draft - Revised Final |
6/24/2022 |
| 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 Compatibilityndividual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility |
|
|
| |
|
|
|
| Administrative / Procedural |
Charging for Investigational Drugs Under an IND: Questions and Answers |
Draft |
8/23/2022 |
| ICH-Safety |
FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products |
Final |
8/15/2022 |
| Electronic Submissions |
Biosearch Monitoring Technical Conformance Guide |
Final |
8/15/2022 |
| Generics |
Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies |
Draft |
8/2/2022 |
| Pharmaceutical Quality |
Changes to Disposable Manufacturing Materials: Questions and Answers Guidance for Industry |
Final |
7/29/2022 |
| Labeling |
Human Prescription Drug and Biological Products--Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers--“Dose Banding” |
Draft |
7/20/2022 |
| Generics |
Evaluation of Therapeutic Equivalence |
Draft |
7/20/2022 |
| Labeling |
Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format |
Final |
7/15/2022 |
| Administrative/Procedural |
Identifying Trading Partners Under the Drug Supply Chain Security Act |
Draft |
7/5/2022 |
| Administrative/Procedural |
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments |
Draft |
6/29/2022 |
| Clinical Pharmacology |
Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics |
Draft |
6/27/2022 |
| Clinical Pharmacology |
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations |
Final |
6/24/2022 |
| Administrative / Procedural |
Considerations for Rescinding Breakthrough Therapy Designation Guidance for Industry |
Draft |
6/24/2022 |
| Pharmaceutical Quality/Current Good Manufacturing Practice (CGMP) |
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination |
Draft - Revised Final |
6/24/2022 |
| 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 |
Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations |
Final |
6/24/2022 |
| Administrative / Procedural |
Considerations for Rescinding Breakthrough Therapy Designation Guidance for Industry |
Draft |
6/24/2022 |
| Pharmaceutical Quality/Current Good Manufacturing Practice (CGMP) |
Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination |
Draft - Revised Final |
6/24/2022 |
| 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 |
