Requests the FDA Granted and Denied for Fast-Track Designation

Note: In addition to requests granted and denied during the period, 33 requests for fast track designation were withdrawn by the sponsor and 7 were classified by FDA as other. According to FDA, the category of other includes cases where the drug application was inactivated, terminated, or cancelled before FDA made a decision (grant or deny) or if the request is still pending.

Data Source: GAO analysis of FDA data.

Source: U.S. Government Accountability Office: Drug Safety: FDA Expedites Many Applications, But Data for Postapproval Oversight Need Improvement