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BIO Comments to FDA on “Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence”

December 18, 2023

In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)

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BIO Comment Letter - FDA-2023-D-2318 - Substantial Evidence AWC
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Following the FDA Workshop to Enhance Clinical Study Diversity on November 29-30, 2023, BIO submits specific comments per the request for information (FDA-2023-N-2462).
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)
BIO provided general comments and recommended edits Re: FDA-2023-D-3031