Archived documents
Documents past their public comment period for Pharmaceutical Policy.
Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List
1,850 comments
Net support +90% across analyzed comments
Top issues in comments
- Compounding safety and access
- Patient access and affordability
- Add specific peptides to 503a list
Drug Repurposing for Unmet Medical Needs; Request for Information
608 comments
Net support +95% across analyzed comments
Top issues in comments
- Drug repurposing for long covid
- Expand fda-approved indications
- Treatment for long covid
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments - Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)
199 comments · 199 awaiting analysis
Analysis in progress
Top issues in comments
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
154 comments
Net support +94% across analyzed comments
Top issues in comments
- Plausible mechanism framework
- Regulatory framework for rare diseases
- Post-approval data collection
General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
125 comments
Net support +82% across analyzed comments
Top issues in comments
- Animal testing alternatives
- Nam weight-of-evidence frameworks
- Nam validation requirements
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance
123 comments · 36 awaiting analysis
Net support +89% across analyzed comments
Top issues in comments
- Ai and ml validation guidelines
- Risk assessment criteria
- Bias and fairness
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
94 comments
Net support -54% across analyzed comments
Top issues in comments
- Patient testimonial of efficacy
- Patient experience with tavneos
- Patient experience and efficacy
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and Comments
69 comments
Net support +80% across analyzed comments
Top issues in comments
- Benefits of pfdd meetings
- Lifecycle of patient engagement
- Patient-centered research and advocacy
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