Archived documents
Documents past their public comment period for Healthcare & Public Health.
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Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance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
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Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection: Draft Guidance for Industry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Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry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
2026-11012
26 comments · 1 awaiting analysis
Net support +44% across analyzed comments
Top issues in comments
- Syringe services program survey design
Master Protocols for Drug and Biological Product Development; Guidance for Industry; Draft Guidance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
Establishing Impurity Specifications for Antibiotics; Draft Guidance for Industry
19 comments
Net support +63% across analyzed comments
Top issues in comments
- Impurity limits and control strategy
- Terminology and definitions
- Analytical method validation
M4Q(R2); The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality; Draft Guidance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
National Healthcare Safety Network (NHSN)
17 comments
Net support +6% across analyzed comments
Top issues in comments
- Nhsn reporting definition accuracy
- Burden of reporting
Self-Attestation for Recertification of CORFs, OPT/SLP, and RHCs Providers and PXR Suppliers (CMS-10952A-D)
17 comments
Net support -88% across analyzed comments
Top issues in comments
- Patient safety and oversight
- Rhc survey and certification procedures
- Reduced on-site survey frequency
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
16 comments · 13 awaiting analysis
Net support +100% across analyzed comments
Top issues in comments
- Bmi limitations and alternatives