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What must a sponsor do to obtain authorization to continue charging for an investigational drug for expanded access use beyond the duration of its existing charging authorization?
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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.  

If a sponsor wishes to continue charging beyond the duration of its existing charging authorization, the sponsor must submit a request to FDA for reauthorization to charge for the investigational drug. 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.

The request must satisfy the same requirements as the initial request for charging authorization. It is also helpful for sponsors to specify whether any information from the original or previous request has changed. The sponsor must receive written reauthorization from FDA before it can continue to charge for the investigational drug beyond the period previously authorized.

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