CDER’s Maria Cecilia Tami and Chunchun Zhang discuss CMC information required for an IND per 21 CFR 312.23. This supports that the investigational drug is safe to be administered to humans especially with reference to the drug substance (including characterization, manufacturing, testing, and stability) and drug product (composition, manufacture, testing and stability) for used in a clinical trial. The presentation includes case studies of CMC related clinical hold issues and discuss how such situations can be successfully addressed in an IND submission.

The review of the CMC portion of a drug intended for use under an investigational new drug application (IND) resides in the Office of New Drug Products (ONDP) and in the Office of Biotechnological Products (OBP). ONDP primarily reviews small molecules while biologics are reviewed by OBP.

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