2023-20452: Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information
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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.
The agency’s own summary, as published.
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