Fast track (FDA)

From WikiMD's Food, Medicine & Wellness Encyclopedia

Fast track is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs which treat a serious or life-threatening condition and fill an unmet medical need. Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days

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Contributors: Prab R. Tumpati, MD