The U.S. Food and Drug Administration (FDA) issued a revised draft guidance, entitled Charging for Investigational Drugs Under an IND Questions and Answers. When finalized, this version will replace the final guidance issued in June of 2016 in response to questions concerning the implementation of the charging regulation.
Who is this guidance intended for?
This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients.
What issues does the guidance address?
The guidance details questions and answers in four general categories:
- General Questions Related to Charging for Clinical Trials and Expanded Access Use
- Charging in Clinical Trials
- Charging for Expanded Access Use
- Cost Recovery Calculations
View the revised guidance page to download the document and to submit a formal comment. The comment period ends on October 24, 2022.
