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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