Archived documents
Documents past their public comment period for FDA.
FDA ▾
Commissioner’s National Priority Voucher (CNPV) Pilot Program; Public Hearing; Request for Comments
508 comments
Net support -24% across analyzed comments
Top issues in comments
- Fast track drug approval
- Reform of nda/bla review process
- Politicization of drug review
AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information
197 comments · 2 awaiting analysis
Net support +93% across analyzed comments
Top issues in comments
- Ai-enabled clinical trial optimization
- Standardized evaluation framework
- Ai bias and healthcare equity
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Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry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
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry
125 comments
Net support -26% across analyzed comments
Top issues in comments
- Flavored vaping products
- Harm reduction
- Relative harm of products
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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance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 · 106 awaiting analysis
Net support +94% across analyzed comments
Top issues in comments
- Ai and ml validation guidelines
- Ai in regulatory writing
- Definition of ai
General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance
118 comments
Net support +81% across analyzed comments
Top issues in comments
- Nam weight-of-evidence frameworks
- Animal testing alternatives
- Nam validation requirements
ChemoCentryx, Inc.; Proposal To Withdraw Approval of New Drug Application for TAVNEOS (Avacopan) Capsule, 10 Milligrams; Opportunity for a Hearing
67 comments
Net support -51% across analyzed comments
Top issues in comments
- Patient safety and efficacy
- Patient experience and efficacy
- Patient experience with avacopan
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance
54 comments
Net support +59% across analyzed comments
Top issues in comments
- Classification of protocol deviations
- Reporting responsibilities for deviations
- Clarity of clinical investigation scope
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
Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance
25 comments
Net support +80% across analyzed comments
Top issues in comments
- Master protocols guidance
- Master protocol design
- Agency corruption and funding
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