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US FDA finalizes guidance on developing, manufacturing CAR T therapies (31-01-2024)

Maryland, 31 Jan 2024: The US Food and Drug Administration (FDA) outlined its thinking on what sponsors should consider when submitting premarket applications for chimeric antigen receptor (CAR) T cell products, including recommendations for its non-clinical, clinical, and manufa......
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Source : Regulatory Focus
US Food and Drug Administration (FDA) chimeric antigen receptor (CAR) T cell products CAR T final guidance

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