Archived documents
Documents past their public comment period for Artificial Intelligence.
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
Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry and Other Interested Parties; Draft Guidance
123 comments · 36 awaiting analysis
Net support +89% across analyzed comments
Top issues in comments
- Ai and ml validation guidelines
- Risk assessment criteria
- Bias and fairness
Agency Information Collection Activities; Proposals, Submissions, and Approvals: Incident Reporting for Automated Driving Systems and Level 2 Advanced Driver Assistance Systems
4 comments
Net support +50% across analyzed comments
Top issues in comments
- Data quality and completeness
- Automated data submission schema