Archived documents
Documents past their public comment period for Pharmaceutical Policy.
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act
3,901 comments · 322 awaiting analysis
Net support +86% across analyzed comments
Top issues in comments
- Safety of compounded glp-1s
- Opposition to glp-1 exclusion
- Patient access and affordability
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
2,641 comments · 55 awaiting analysis
Net support +86% across analyzed comments
Top issues in comments
- Compounding safety and access
- Patient access and affordability
- Peptide efficacy for healing
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Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
156 comments · 2 awaiting analysis
Net support +94% across analyzed comments
Top issues in comments
- Plausible mechanism framework
- Regulatory framework for rare diseases
- Post-approval data collection
Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments—Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec
130 comments · 130 awaiting analysis
Analysis in progress
Top issues in comments
General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance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
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance
76 comments · 28 awaiting analysis
Net support +63% across analyzed comments
Top issues in comments
- Nonclinical safety assessment streamlining
- Animal testing
- Animal testing alternatives
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
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.
69 comments · 11 awaiting analysis
Net support -14% across analyzed comments
Top issues in comments
- Patient health and quality of life
- Vaccine safety and efficacy
- Vaccine updates and accessibility