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Charging for Investigational Drugs Under an IND: Questions and Answers August 2022

Draft Level 1 Revised Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0447

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs

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 FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions. 

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