Expanded Access to Investigational Drugs for Treatment Use-Questions and Answers; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Expanded Access to Investigational Drugs for Treatment Use--Questions and Answers." The 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). FDA received a number of questions concerning implementation of its expanded access regulations and is providing guidance in a question and answer format to address the most frequently asked questions. This guidance finalizes the draft guidance issued in May 2013.