Frequently Asked Questions
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?
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.