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Fast track designation

Fast track designation is a designation that a drug company must request from the FDA, which decides whether to grant it based on whether the drug fills an unmet medical need in a serious condition[1]. It belongs to the fast track process, which is designed to facilitate the development, and expedite the review, of such drugs[1].

A request for the designation may be made at the same time as the application to investigate the drug, or at any time after it[1]. The FDA reviews the request and decides within sixty days[1].

Whether a condition is serious is a matter of judgement, but it generally rests on whether the drug will affect factors such as survival, day-to-day functioning, or the likelihood that the condition will progress to a more serious one[1]. Filling an unmet medical need means providing a therapy where none exists, or one that may be potentially better than the available therapy[1]. If there are available therapies, a fast track drug must show some advantage over them[1]. One example is decreasing a clinically significant toxicity of an available therapy that is common and causes treatment to be discontinued[1].

A drug with the designation is eligible for some or all of a set of features[2]. These include more frequent meetings with the FDA about the development plan and the data needed to support approval[1]. They also include more frequent written communication from the FDA about matters such as clinical trial design and the use of biomarkers[1]. Another is rolling review, where the company can submit completed sections of its BLA or NDA for review instead of waiting until every section is finished[1]. Review of the application usually does not begin until the entire application has been submitted[1].

Related: Accelerated approval, Priority review, Breakthrough therapy designation, New Drug Application (NDA)