Archived documents
Documents past their public comment period for Healthcare & Public Health.
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Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry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General Considerations for the Use of New Approach Methodologies in Drug Development; Guidance for Industry - Draft Guidance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
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications—Considerations Related to Youth Risk - Draft Guidance for Industry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Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance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 · 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
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Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products; Guidance for Industry - Draft Guidance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
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
Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments
69 comments · 13 awaiting analysis
Net support +45% across analyzed comments
Top issues in comments
- Oral fluid and hair testing
- Exemption framework scope and flexibility
- Oral fluid testing certification
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