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FDA fast track program

With its fast track drug development programs, the FDA seeks to facilitate the development of new drugs and speed up their approval process. This is especially true in case of drugs that can provide for unmet medical needs pertaining to debilitating or life-threatening diseases such as cancer. An unmet medical need is said to exist when no standard treatment is available for a specific disease or condition or when the existing treatment is not effective. Based on these factors, drug sponsors may request the FDA to assign the fast track designation to the new drug. If approved, the drug may come under the purview of a fast track program, which can speed up the approval process.