Archived documents
Documents past their public comment period for Pharmaceutical Policy.
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance
19 comments
Net support +63% across analyzed comments
Top issues in comments
- Content clarity and detail
- Document organization and logic
- Analytical procedure documentation
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry
17 comments
Net support +65% across analyzed comments
Top issues in comments
- Impurity limits and control strategy
- Terminology and definitions
- Analytical method validation
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry
13 comments · 8 awaiting analysis
Net support +40% across analyzed comments
Top issues in comments
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Guidance for Industry; Draft Guidance
7 comments · 7 awaiting analysis
Analysis in progress
Top issues in comments
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
6 comments · 5 awaiting analysis
Net support 0% across analyzed comments
Top issues in comments
Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
4 comments
Net support +75% across analyzed comments
Top issues in comments
- Independent batch testing
- Nitrosation reaction rate
- Pediatric drug development
Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Safety and Effectiveness of MFLUSIVA (Influenza Vaccine, mRNA) Manufactured by Moderna TX Inc.
4 comments
Net support +100% across analyzed comments
Top issues in comments
- Mrna vaccine manufacturing efficiency
- National medical leadership
- Patient health and quality of life
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
2 comments
Net support +100% across analyzed comments
Top issues in comments
- Bmi limitations and alternatives
Clinical Pharmacology Considerations for Peptide Drug Products Guidance for Industry - DRAFT GUIDANCE
2 comments · 2 awaiting analysis
Analysis in progress
Top issues in comments
2026-08586
1 comment
Net support +100% across analyzed comments
Top issues in comments
Schedules of Controlled Substances: Removal of Exemption Status for Inactive Butalbital Products
1 comment
Net support -100% across analyzed comments
Top issues in comments
- Methodology for identifying discontinued products
2026-08585
0 comments
Analysis in progress
Top issues in comments