Archived documents
Documents past their public comment period for FDA.
FDA ▾
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators; Draft Guidance for Industry and Food and Drug Administration Staff
7 comments
Net support +100% across analyzed comments
Top issues in comments
- Regulatory oversight and clarity
- Clarify intended audience
- Occupational safety and heat stress
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance
6 comments · 5 awaiting analysis
Net support 0% across analyzed comments
Top issues in comments
Challenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments
6 comments
Net support +67% across analyzed comments
Top issues in comments
- Gs1 standards adoption
- Imprinting requirements on individual packages
- Mobile application for traceability
Fiscal Year 2026 Generic Drug Science and Research Initiatives Workshop; Public Workshop; Request for Comments
4 comments
Net support +75% across analyzed comments
Top issues in comments
- Independent batch testing
- Nitrosation reaction rate
- Pediatric drug development
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.
4 comments
Net support +100% across analyzed comments
Top issues in comments
- Mrna vaccine manufacturing efficiency
- National medical leadership
- Patient health and quality of life
Obesity and Drug Dosing: Clinical Pharmacology Considerations; Request for Comments
2 comments
Net support +100% across analyzed comments
Top issues in comments
- Bmi limitations and alternatives
Clinical Pharmacology Considerations for Peptide Drug Products Guidance for Industry - DRAFT GUIDANCE
2 comments · 2 awaiting analysis
Analysis in progress
Top issues in comments
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
2 comments
Net support -50% across analyzed comments
Top issues in comments
- Compounded glp-1 drugs
- Compounding pharmacy access
Color Additive Petition submitted seeking amended color additive regulations to remove FDA's approval of three carcinogenic solvents
1 comment
Net support +100% across analyzed comments
Top issues in comments
Infant Formula Transition Plan for Exercise of Enforcement Discretion: Guidance for Industry
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Ingredient safety concerns
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications On Medical Devices and Radiation-Emitting Products
1 comment
Net support +100% across analyzed comments
Top issues in comments
Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products; Request for Information and Comments
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Qualification of digitally-derived endpoints