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In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.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 Board Vice Chair and CEO of Amicus Therapeutics testified that the drug price controls in the Inflation Reduction Act harm drug research and development.
BIO joined with other groups in writing House and Senate Agriculture Committee leaders in support of agricultural research (FFAR) funding in the farm bill.
In these comments, BIO addresses FDA’s four specific topic areas of consideration as the agency develops its draft guidance per PDUFA VII.