BIO Comments to FDA (Docket No. FDA-2023-N-0398) on Methods and Approaches for Capturing Post-Approval Safety and Efficacy Data on Cell and Gene Therapy Products
May 26, 2023
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
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.
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.