About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Senior Quality Assurance & Regulatory Affairs Manager
Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process.

Charging for an investigational drug for expanded access use may continue for 1 year from the time of FDA authorization unless FDA specifies a shorter period. FDA periodically reassesses whether charging is interfering with development of a drug for marketing and believes that the 1-year anniversary is typically a reasonable point in time to reevaluate charging requests.

FDA may reauthorize charging for an investigational drug for expanded access use for additional periods. If a sponsor wishes to continue charging beyond the expiration of the existing authorization, FDA recommends that the sponsor submit a request to reauthorize charging at least 60 days prior to the expiration of the existing authorization to charge for the investigational drug.

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