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31st August 2022
Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry
This guidance provides information for industry, researchers, physicians, institutional review 18 boards (IRBs), and patients about the implementation of FDA’s regulations on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009.