Fast track (FDA)

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Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. Fast track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.

Contents

Purpose

Fast track is one of five FDA approaches to make new drugs available as rapidly as possible: [1] the others are priority review, breakthrough therapy, accelerated approval and regenerative medicine advanced therapy.

Fast track was introduced by the FDA Modernization Act of 1997. [2]

Requirements

Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.

Serious condition: determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will affect such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.

Unmet medical need: for a drug to address an unmet medical need, the drug may be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:

Incentives

A drug that receives a fast track designation is eligible for some or all of the following: [3]

An FDA decision not to grant fast track status, or any other general dispute, may be appealed to the division responsible for reviewing the application within the Center for Drug Evaluation and Research. The drug sponsor can subsequently utilize the Agency's procedures for internal review or dispute resolution if necessary.

Once a drug receives fast track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

See also

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References

  1. Fast Track, Breakthrough Therapy, Accelerated Approval, Priority Review.
  2. "Immunomedics Awarded Fast Track Designation by FDA for Sacituzumab Govitecan (IMMU-132) for Triple-Negative Breast Cancer Therapy". GlobeNewswire News Room (Press release). 5 January 2015.
  3. Commissioner, Office of the (3 November 2018). "Fast Track". FDA via www.fda.gov.