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How long may a sponsor charge for an investigational drug for expanded access use after FDA authorizes the charging?
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About the Author
Proxima CRO Team
Ellie Reynolds, MBE
Regulatory Affairs Manager

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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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