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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers Guidance for Industry June 2016

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations on expanded access to investigational drugs for treatment use under an investigational new drug application (IND) (21 CFR part 312, subpart I), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning implementation of the regulations. As a result, FDA is providing guidance in a question and answer format, addressing the most frequently asked questions. In a separate guidance, FDA provides answers to questions concerning the implementation of the regulation on charging for investigational drugs under an IND (21 CFR 312.8). Also in a separate guidance, FDA describes Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)) and the process for submitting expanded access requests for individual patient INDs.

Submit Comments

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:

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-0446.

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