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FDA Fast Track Development Program
The FDA Fast Track Designation is a designation of the United States Food and Drug Administration (FDA) that facilitates the development, and expedites the review, 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.
== Purpose ==
The purpose of Fast Track designation is to get important new drugs to the patient earlier.
It was introduced by the FDA Modernization Act of 1997.〔()〕
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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