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BIO Comments to FDA on “Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products”

December 18, 2023

In response to the request for information and comments, BIO submitted general comments and recommended edits (FDA-2017-D-6530)

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BIO Comment Letter - FDA-2017-D-6530 - Formal Meetings PDUFA
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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-2023-D-2318)
BIO provided general comments and recommended edits Re: FDA-2023-D-3031