Fast-track designation

Fast track designation is a designation by the United States Food and Drug Administration (FDA) of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. The designation must be requested by the drug company. The FDA grants Fast Track Designation to drugs that are believed to have an impact on patient survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. The designation allows the manufacturer or drug developer to meet and communicate more frequently with the FDA.

Course: REG210