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FEDERAL REGISTER · NOTICESeptember 21, 2023NOTICE — NO LEGAL EFFECT

Scientific Challenges and Opportunities To Advance the Development of Individualized Cellular and Gene Therapies; Request for Information

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSENov 20, 2023 · closed
APPLIES TO · SPEQ TAGBiologics
Document type
Notice
Agency
Health and Human Services Department
Published
September 21, 2023
Comments close
November 20, 2023
Document number
2023-20452
Docket
FDA-2023-N-3742
ABSTRACT

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.

Abstract as published in the Federal Register.

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