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  1. Center for Biologics Evaluation and Research (CBER)

Fast Track Designation Request Performance

The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs." This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a "rolling review" for an application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.

To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER's performance in reviewing and deciding on these requests.

Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics - 5/2014; Appendix 2; Appendix 3 - (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.

CBER "Fast Track" Designation Request Performance Report
All Requests Received
(March 1, 1998 through January 31, 2024)

Number Submitted Goal Within Goal Overdue
Granted Denied Pending Total % Granted Denied Pending Total %
60 days

*Does not include three requests received by OTRR and pending on October 1, 2003. Final actions on those requests are counted in CDER reports.

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