Archived documents
Documents past their public comment period for Biomedical Research.
Drug Repurposing for Unmet Medical Needs; Request for Information
608 comments
Net support +95% across analyzed comments
Top issues in comments
- Drug repurposing for long covid
- Expand fda-approved indications
- Treatment for long covid
AI-Enabled Optimization of Early- Phase Clinical Trials Pilot Program; Request for Information
239 comments · 2 awaiting analysis
Net support +94% across analyzed comments
Top issues in comments
- Ai-enabled clinical trial optimization
- Standardized evaluation framework
- Ai bias and healthcare equity
Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Guidance for Industry - Draft Guidance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
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Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-inHuman (FIH) Trials; Guidance for Industry; Draft Guidance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
Focus on Advancing Support and Transition with the Fragile X Online Registry with Accessible Research Database (FAST FORWARD)
2 comments
Net support +50% across analyzed comments
Top issues in comments
- Funding for fxs activities
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
Biomarker Incubator: Urinary Kidney Safety Biomarkers; Request for Information
1 comment
Net support +100% across analyzed comments
Top issues in comments
- Pediatric and neonatal considerations
Psychedelic Drugs: Considerations for Clinical Investigations; Guidance for Industry; Draft Guidance
0 comments
Analysis in progress
Top issues in comments
Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
0 comments
Analysis in progress
Top issues in comments
Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
0 comments
Analysis in progress
Top issues in comments
Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators - Draft Guidance
0 comments
Analysis in progress
Top issues in comments