OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer
FDA Law Blog: Drug Discovery
JANUARY 4, 2023
The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. Manufacturers who hold a biological license should report manufacturing deviations to the FDA per 21 CFR 600.14.
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