Scientific challenges and opportunities to advance the development of individualized cellular and gene therapies; Request for information
The Food and Drug Administration (FDA or Agency), Center for Biologics Evaluation and Research (CBER) is requesting information from stakeholders regarding critical scientific challenges and opportunities to advance the development of individualized cellular and gene therapies (CGTs).
FDA intends to gather information and comments submitted in response to this request for information (RFI) to inform potential planning of future town halls, workshops, or discussion papers which could ultimately facilitate the development of additional regulatory science tools, standards, or guidance.
Either electronic or written comments on the notice must be submitted by November 20, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern time at the end of November 20, 2023. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
