FDA - Guidance Documents for Consultation

28th March 2024

FDA

Guidance Documents open for public consultation:

• Handling and Retention of Bioavailability BA and Bioequivalence BE Testing Samples
• Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
• Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program - Draft Guidance for Industry and Food and Drug Administration Staff

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