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BIO Comments to FDA on Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

November 21, 2023

BIO provided general comments and recommended edits Re: FDA-2023-D-3031

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BIO Comment Letter - FDA-2023-D-3031 - Alternative Tools
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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)
In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2023-D-2318)