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BIO Comments to FDA on Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products, and Devices

July 26, 2023

BIO submitted general comments and specific recommendations to the FDA in response to the agency's request for information. (Docket FDA-2022-D-2870)

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BIO Comment Letter - FDA-2022-D-2870 DCT
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In response to the agency's request for information (Docket No. FDA-2023-N-0743-0002), BIO provides detailed comments.
BIO provides detailed comments in advance of the July 31, 2023 NIH Workshop, “Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer.