FDA Fast Track Development Program

FDA Fast Track Development Program

FDA Fast Track Development Program

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Description:
The FDA Fast Track Development Program is a designation of the United States Food and Drug Administration (FDA) that accelerates the approval of investigational new drugs undergoing clinical trials. Such status is often given to agents that show promise in treating serious, life-threatening medical conditions for which no other drug either exists or works as well.

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious diseases. Determining whether a disease is serious 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 disease, if left untreated, will progress from a less severe condition to a more serious one.

Any drug being developed to treat or prevent a disease with no current therapy obviously is directed at an unmet need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as:

  • Showing superior effectiveness
  • Avoiding serious side effects of an available treatment
  • Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
  • Decreasing a clinically significant toxicity of an accepted treatment


A drug that receives Fast Track designation is eligible for...
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