Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application-Questions and Answers; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Charging for Investigational Drugs Under an IND--Qs & As." This guidance is intended to provide information for industry, researchers, and physicians on how FDA is implementing its regulation on charging for an investigational drug under an investigational new drug (IND) application. FDA has received a number of questions about how it is implementing the charging regulation. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions and answers, including questions about charging for investigational drugs made available under expanded access programs.