FDA Issues Revised Draft Guidance on Charging for Investigational Drugs Under an Investigational New Drug Application

August 2022

Draft Guidance

This guidance provides information for industry, researchers, physicians, institutional review 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. Since 2009, FDA has received a number of questions concerning its implementation of the charging regulations. As a result, FDA issued the final guidance for industry Charging for Investigational Drugs Under an IND — Questions and Answers in June 2016. Since issuance of the final guidance, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions.

Download the Draft Guidance Document

Draft     Level 1 Revised Guidance

Read the Federal Register Notice

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