September 27, 2023
The Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) is requesting information from stakeholders about scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs). The feedback will inform potential planning of future town halls, workshops or discussion papers that could ultimately facilitate the development of additional regulatory science tools, standards or guidance.
The Sept. 21 Federal Register notice (FRN) outlines the following four topic areas on which the agency is seeking feedback, along with sample questions:
FDA is accepting written or electronic comments on from the public through 11:59 p.m. ET on Monday, Nov. 20. Instructions are available in the FRN.