Charging for Investigational Drugs Under an IND: Questions and Answers August 2022
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and ResearchOffice 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 FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.