Maria Cecilia Tami and Balajee Shanmugam review the Chemistry, Manufacturing and Controls (CMC) portion of a drug intended for use under an investigational new drug application (IND). The review resides in the Office of New Drug Products (ONDP) and in the Office of Biotechnological Products (OBP). ONDP reviews small molecules while biologics are reviewed by OBP.
This session discusses the CMC information for small molecules and biologics required for an IND per 21 CFR 312.23, especially with reference to the drug substance (characterization, manufacturing, testing, and stability) and drug product (composition, manufacture, testing and stability), to support that the investigational drug is reasonably safe for use in a clinical trial. The presentation will also discuss case studies of CMC related clinical hold issues.
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