FDA Fast Track and Priority Review Programs (CRS Report for Congress)
| Release Date |
Feb. 21, 2008 |
| Report Number |
RS22814 |
| Report Type |
Report |
| Authors |
Susan Thaul, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
Summary:
By statutory requirements and by regulation, guidance, and practice, the Food and Drug Administration (FDA) works with several overlapping yet distinct programs to get to market quickly new drug and biological products that address unmet needs. FDA most frequently uses three mechanisms for that purpose: Accelerated Approval, Fast Track, and Priority Review. The first two affect the development process before a sponsor submits a marketing application. Accelerated Approval allows surrogate endpoints in trials to demonstrate effectiveness and is relevant in fewer situations than the others. The Fast Track program encourages a sponsor to consult with FDA while developing a product. Unlike the others, Priority Review involves no discussions of study design or procedure; it relates only to an application's place in the review queue. Analysis of total approval time for 'approved' applications under the Fast Track and Priority Review programs shows that for seven of the past nine years, Fast Track products have shorter median approval times than do all those applications assigned to Priority Review.
