Order Code RS22814
February 21, 2008

FDA Fast Track and Priority Review Programs
Susan Thaul
Specialist in Drug Safety and Effectiveness
Domestic Social Policy Division

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.

It takes an average of 15 years from the moment a manufacturer first approaches the
Food and Drug Administration (FDA) with an idea for a new drug to its final approval for marketing.1 Steps in the development and approval of a drug or biologic (e.g., a vaccine) involve actions by both the manufacturer and FDA. First, a manufacturer (sometimes referred to as the sponsor) submits to FDA an Investigational New Drug (IND) application for permission to conduct clinical studies in humans. Second, the manufacturer completes Phase I, II, and III clinical trials to establish that a