Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

Abstract

With the passage of the Food and Drug Administration Modernization Act (FDAMA), existing programs for expedited development and approval for treatments of serious or life-threatening diseases were codified and consolidated under the administrative rubric of fast track product designation. The four basic programs available with fast track designation have been categorized by FDA as consisting of meetings, written correspondence, review programs, and dispute resolution. Despite some early skepticism by industry, and even FDA, that the benefits of designation were not readily apparent since the individual programs are generally available without designation, there are indications that fast track designation will be the improvement Congress intended. Unlike the individual expedited development and approval programs, which affect only part of the drug development timeline, fast track designation has the potential to facilitate the entire process. Industry requests for fast track designation have dwarfed pre-FDAMA industry participation. Yet, the best predictor of the future success or failure of fast track designation is how well it is working now. In order to evaluate this, the authors surveyed the biotechnology and pharmaceutical sponsors of 32 fast track designated products identified from public information sources and present their findings in this paper.

Keywords

Fast track Fast track designation FDA Modernization Act FDAMA Food and Drug Administration Expedited development Accelerated approval Rolling review FDA-sponsor meetings Priority review

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