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BIO Comments to FDA on the draft guidance “Regulatory Consideration for Prescription Drug Use-Related Software.”

December 18, 2023

In response to the request for information and comments, BIO submitted general comments and recommended edits on the draft guidance (FDA-2023-D-2482)

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BIO Comment Letter - FDA-2023-D-2482 - Prescription Drug Use-Related Software
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Dear Mr. Thune, Mr. Schumer, Mr. Johnson, and Mr. Jeffries:As President and CEO of the Biotechnology Innovation Organization (BIO), as a father and entrepreneur whose family is here today because of biotech innovation, and on behalf of the more than…