The FDA Fast Track Designation: A Primer

Picture1By Peter Martin, M.D.

The Fast Track Designation was introduced by the FDA in 1997 under the FDA Modernization Act. It was designed to speed up the development and review of drugs that treat serious conditions and fill an unmet medical need. Like all expedited designations, the Fast Track was designed to get new treatments into the hands of patients in need.

The Fast Track designation must be requested by the treatment’s sponsor. To determine whether a treatment warrants a Fast Track designation the FDA decides whether a drug shows promise in treating a serious condition or fills an unmet medical need. Determining whether a drug treats a condition that is “serious” is largely a subjective matter, but cancers including lymphoma are universally agreed upon to match the criteria of serious conditions. The factors the FDA will consider include the drug’s impact on survival, day-to-day functioning, and if left untreated, whether a less severe condition will turn into a more serious condition. An unmet medical need provides a treatment option to patients where no such option previously existed.

If other treatment options are already available then the treatment applying for the Fast Track designation must show superior effectiveness, avoid any major side effects found in currently available therapies, improve upon the diagnosis to show an improved outcome, or address an emerging or anticipated public health need.

Treatments that meet these criteria are eligible for more support from the FDA for their application process. If the relevant criteria is met they are also eligible for the accelerated approval and priority review designations.

Previous Entries in the Primer Series

The FDA Approval Process
The FDA Breakthrough Therapy Designation
The FDA Accelerated Approval Designation
The FDA Priority Review Designation

Author: lymphomaprogram

Located on the Upper East Side of New York City, the Lymphoma Program at Weill Cornell Medical College/NewYork Presbyterian Hospital is internationally recognized for our efforts to enable patients with non-Hodgkin lymphoma, Hodgkin disease and related disorders to have the best possible clinical outcome, including cure when possible.

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