Archived documents
Documents past their public comment period for FDA.
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Clinical Pharmacology Considerations for Peptide Drug Products Guidance for Industry - DRAFT GUIDANCE
3 comments · 2 awaiting analysis
Net support 0% across analyzed comments
Top issues in comments
Agency Information Collection Activities; Proposed Collection; Comment Request; Good Laboratory Practice Requirements for Nonclinical Laboratory Studies
3 comments · 1 awaiting analysis
Net support -50% across analyzed comments
Top issues in comments
- Compounded glp-1 drugs
- Compounding pharmacy access
Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act
2 comments · 1 awaiting analysis
Net support +100% across analyzed comments
Top issues in comments
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
Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs
1 comment · 1 awaiting analysis
Analysis in progress
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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
Pediatric Dosing Information for Over-the-Counter Human Drugs; Intent and Request for Information
1 comment · 1 awaiting analysis
Analysis in progress
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PSG_020076 - Draft Guidance on Nicotine
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Public health benefits of lower nicotine
Notice of Filing Miles Laboratories, Inc.; Filing of A Petition for Affirmation of GRAS Status
0 comments
Analysis in progress
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Food Additives Permitted for Direct Addition to Food for Human Consumption; Sucralose
0 comments
Analysis in progress
Top issues in comments