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

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Charging for Investigational Drugs Under an IND: Questions and Answers." This guidance addresses frequently asked questions related 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. This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.