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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.
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to submit comments regarding the request and comments on the Advanced Manufacturing Technologies Designation Program Draft Guidance.
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…
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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.