FDA - Draft Guidance on Charging for Investigational Drugs Under an IND

31st August 2022

FDA

Charging for Investigational Drugs Under an IND Questions and Answers - Guidance for Industry
DRAFT GUIDANCE.

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.

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