Archived documents
Documents past their public comment period for Pharmaceutical Policy.
Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request for Comments
52 comments · 2 awaiting analysis
Net support +94% across analyzed comments
Top issues in comments
- Supac guidance clarity
- Guidance consolidation
- Additional change types
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry
42 comments
Net support +76% across analyzed comments
Top issues in comments
- Response format and content
- Scope of guidance application
- Attorney-client privilege and disclosure
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
33 comments
Net support +85% across analyzed comments
Top issues in comments
- Variant-aware off-target analysis
- Optical genome mapping (ogm)
- Rare disease flexibility
Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance
26 comments
Net support +81% across analyzed comments
Top issues in comments
- Master protocols guidance
- Master protocol design
- Agency corruption and funding
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry
19 comments
Net support +63% across analyzed comments
Top issues in comments
- Impurity limits and control strategy
- Terminology and definitions
- Analytical method validation
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
16 comments · 13 awaiting analysis
Net support +100% across analyzed comments
Top issues in comments
- Bmi limitations and alternatives
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Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry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
Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
9 comments · 4 awaiting analysis
Net support +80% across analyzed comments
Top issues in comments
- Independent batch testing
- Nitrosation reaction rate
- Pediatric drug development
Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment; Guidance for Industry; Draft Guidance
8 comments · 7 awaiting analysis
Net support -100% across analyzed comments
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
Clinical Pharmacology Considerations for Peptide Drug Products Guidance for Industry - DRAFT GUIDANCE
3 comments · 2 awaiting analysis
Net support 0% across analyzed comments
Top issues in comments