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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog: Drug Discovery

JANUARY 4, 2023

There was a lot of information on CMC regulatory requirements and pitfalls for cellular therapies and tissue engineered products discussed during the OTAT town hall that are not included in this blog. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

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