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GUIDANCE DOCUMENT

Charging for Investigational Drugs Under an IND: Questions and Answers February 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-0447
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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 This guidance finalizes the revised draft guidance of the same title issued on August 23, 2022, and replaces the final guidance issued on June 3, 2016.

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All written comments should be identified with this document's docket number: FDA-2013-D-0447.

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