Charging for Investigational Drugs Under an Investigational New Drug Application-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 "Charging for Investigational Drugs Under an IND--Questions and Answers." The guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA's regulation 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. FDA received a number of questions concerning its implementation of the charging regulation. FDA is providing guidance in a question and answer format to address the most frequently asked questions about charging for investigational drugs under an IND. This guidance finalizes the draft guidance issued in May 2013.