Documents
Federal rules and notices from the public comment record, analyzed continuously.
FDA ▾
Questions and Answers on Biosimilar Development and the BPCI Act - Guidance for Industry
1 comment
Net support -100% across analyzed comments
Top issues in comments
- Use of non-u.s.-licensed comparator products
Citizen Petition from Covington & Burling LLP on behalf of Novo Nordisk Inc.
1 comment · 1 awaiting analysis
Analysis in progress
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Electronic Method for Specific Electronic Submissions to FDA's Dockets Management Staff
1 comment · 1 awaiting analysis
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Computer Software Assurance for Production and Quality Management System Software Guidance for Industry and Food and Drug Administration Staff
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Ai and ml tools in csa
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization - Guidance for Industry
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Flavored e-cigarette pmta authorization
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry (GFI) #152
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Analysis in progress
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PSG_017769 - Draft Guidance on Calcitonin Salmon
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PSG_020928 - Draft Guidance on Glucagon
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PSG_021318 - Draft Guidance on Teriparatide
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PSG_022341 - Draft Guidance on Liraglutide
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PSG_206321 - Draft Guidance on Liraglutide
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PSG_209637 - Draft Guidance on Semaglutide
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Analysis in progress
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