Charging for Investigational Drugs Under an Investigational New Drug Application: Questions and Answers; Revised Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Charging for Investigational Drugs Under an IND: Questions and Answers." Since issuance of the final guidance in 2016, FDA has received questions from stakeholders through the docket and in the form of communications with review divisions. These questions relate to 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 FDA is providing this revised draft guidance in a question-and-answer format, addressing the most recently asked questions. When finalized, this revised draft guidance will replace the final guidance of the same title issued in June 2016.