U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Guidances (Drugs)
  5. Newly Added Guidance Documents
  1. Guidances (Drugs)

Newly Added Guidance Documents

Below is a sortable list of the most recently added Guidance Documents.

You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Newly Added Guidance Documents

Topic Guidance Status Date
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
Back to Top