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BIO Comments to FDA on their Draft Report and Plan on Best Practices for Guidance

March 4, 2024

The Biotechnology Innovation Organization thanks the Food and Drug Administration for the opportunity to submit comments regarding the request for information and comments on the Food and Drug Administration's Draft Report and Plan on Best Practices for Guidance.

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BIO Comments to FDA on their Draft Report and Plan on Best Practices for Guidance

BIO provides specific comments to the Food and Drug Administration RE: FDA-2023-N-5653

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The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
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)