Archived documents
Documents past their public comment period for Healthcare & Public Health.
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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance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
Revising Definition of Unlawful User of or Addicted to Controlled Substance
101 comments
Net support +45% across analyzed comments
Top issues in comments
- Definition of unlawful user
- Second amendment rights
- Substance use and firearm rights
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
CY 2027 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies (CMS-1848-P Display)
73 comments
Net support -88% across analyzed comments
Top issues in comments
- Payment adequacy
- Access to care
- Modifier 25 reimbursement
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
Request for Information: Pharmacy Benefit Manager Compensation and Data Collection
57 comments
Net support +100% across analyzed comments
Top issues in comments
- Definition of affiliate
- Pbm practices and reimbursement
- Pbm transparency and accountability
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance
55 comments
Net support +60% across analyzed comments
Top issues in comments
- Classification of protocol deviations
- Reporting responsibilities for deviations
- Guidance specificity and rigor
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
53 comments
Net support +45% across analyzed comments
Top issues in comments
- Oral fluid and hair testing
- Exemption framework scope and flexibility
- Oral fluid testing certification
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