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Priority Review and Fast Track
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Overview
Priority Review and Fast Track are expedited regulatory designations granted by the U.S. Food and Drug Administration (FDA) to speed up the development and review of drugs that treat serious or life-threatening conditions and address unmet medical needs. Both programs aim to improve patient access to important therapies, but they differ in their purpose, timing, and impact on the regulatory process.
Fast Track Designation
Fast Track is designed to facilitate the development and expedite the review of drugs intended to treat serious conditions where there is an unmet medical need. This designation is usually granted during the development phase, based on early scientific evidence.
To qualify for Fast Track, a drug must target a serious or life-threatening disease and show the potential to address an unmet medical need. The supporting evidence may come from nonclinical studies or early clinical data.
Fast Track offers several important benefits. Sponsors receive early and frequent communication with the FDA, which helps resolve scientific and regulatory issues at an early stage. The FDA also provides guidance on study design and data requirements. One of the most important features of Fast Track is the option for rolling review, which allows companies to submit completed sections of the marketing application as they become available, rather than waiting for the entire application to be completed. Drugs with Fast Track designation may also become eligible for Priority Review or Accelerated Approval if they meet the required criteria.
The main purpose of Fast Track is to shorten development time, improve communication with regulators, and increase the efficiency of clinical development.
Priority Review
Priority Review is a designation that shortens the FDA’s review timeline for a marketing application. It is granted when the submitted application demonstrates significant improvements in safety or effectiveness compared with existing treatments, or when it addresses a serious condition with an unmet medical need.
Under the standard review process, the FDA typically takes about ten months to review a New Drug Application or Biologics License Application. With Priority Review, this timeline is reduced to approximately six months.
Priority Review is applied at the time of marketing application submission rather than during the development phase. It focuses only on the review timeline and does not change the amount or type of data required. The application still undergoes a full and rigorous scientific evaluation, but within a shorter timeframe.
Key Differences Between Fast Track and Priority Review
Fast Track is granted during the drug development phase, while Priority Review is granted at the time of marketing application submission. The primary purpose of Fast Track is to speed up development and improve communication between the sponsor and the FDA. In contrast, Priority Review is specifically designed to shorten the FDA’s review time for the final application.
Fast Track allows rolling submission of application sections, whereas Priority Review is not directly associated with rolling submissions. Fast Track does not guarantee a specific reduction in review time, but it facilitates the overall process. Priority Review, however, reduces the formal review timeline from ten months to six months.
Despite these differences, both programs require full demonstration of safety and efficacy before approval.
Relationship Between the Two Programs
A drug that receives Fast Track designation during development may later qualify for Priority Review at the time of application submission if it meets the necessary criteria. These programs are not mutually exclusive and may be used together. In some cases, they can also be combined with other expedited programs such as Breakthrough Therapy designation or Accelerated Approval.
Together, Fast Track and Priority Review help ensure that important new treatments reach patients more quickly while maintaining the FDA’s standards for safety, efficacy, and quality.
