Lexology September 22, 2022
Akin Gump Strauss Hauer & Feld LLP

On August 23, 2022, the United States Food and Drug Administration (FDA or the “Agency”) published the revised draft guidance “Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry” (the “Draft Guidance”). Potentially interested stakeholders, including industry, researchers, physicians, institutional review boards and patients, are invited to provide comments to FDA on the Draft Guidance by October 24, 2022.

The Draft Guidance addresses a number of stakeholder questions FDA has received since their publication of an earlier final guidance in 2016 that provided information about the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 (the...

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