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USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational Drugs Under an IND: Questions and Answers".


In this guidance, the FDA addresses frequently asked questions related to the implementation of its regulation on charging for investigational drugs used in clinical trials or for expanded access to treatment.


Several changes have been made to the earlier 2016 version, including

  • the requirement that an independent certified public accountant submit a statement in certain circumstances, and

  • how manufacturing, administrative, or monitoring costs should be distributed throughout the duration of the IND or protocol for expanded access.

In this guidance, questions and answers are organized as follows:

  1. General Questions Related to Clinical Trials and Expanded Access Use,

  2. Charging in Clinical Trials,

  3. Charging for Expanded Access Use, and

  4. Cost Recovery Calculations.

The updated charging regulation offers the following:

  • General criteria for authorizing charging for an investigational drug

  • Criteria for charging for an investigational drug in a clinical trial

  • Criteria for charging for an investigational drug for an expanded access use under part 312, subpart I

  • Criteria for determining what costs can be recovered when charging for an investigational drug

To know the General Questions Related to Charging for Clinical Trials and Expanded Access Use, etc click this LINK.




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