CBER Fast Track Performance: Two-Thirds of Requests Granted

Regulatory NewsRegulatory News | 23 July 2018 |  By 

From March 1998 through the end of June, FDA’s Center for Biologics Evaluation and Research (CBER) granted fast track designations to more than two-thirds of all requests, according to the latest statistics.



The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, "Expediting study and approval of fast track drugs," mandating that the agency 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. 

The fast track designation adds to existing expedited programs, such as accelerated approval and the breakthrough designation, and features 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,” FDA explains.

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.

More details on the fast track program can be found in: Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics.


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