Fast Track Designation

Fast track designation was introduced to expedite the progress and review of new drugs designed to treat serious illnesses or fill an unmet medical need.  This designation’s primary intent is to get these important, possibly life-altering drugs, to the patient faster.

According to the FDA, “filing an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.”

As for the types of drugs that are granted fast track approval, the FDA states it “is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.”  This also includes any new drugs being developed to treat an illness that a current therapy does not exist for. If available therapies do exist, the drug must show a competitive advantage over the existing treatments. These benefits can range from effectiveness to avoiding a bad side effect. Examples of serious conditions that could receive fast track designation include AIDS, cancer, and less obvious ailments like depression.  

Fast track designation must be requested by the drug company and the FDA will review the case and make a decision within 60 days.  If approved, frequent communication between the drug company and agency is recommended as it will ensure that problems and questions are fixed quickly which can lead to earlier drug approval than anticipated.

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