Accelerated Approval

Designation assigned to a drug by the Food and Drug Administration (FDA) intended to make promising products for life-threatening diseases available on the market on the basis of preliminary evidence prior to formal demonstration of patient benefit. In this case, clinical studies and subsequent FDA evaluation are based on a surrogate marker that is considered likely to predict patient benefit. The marketing approval that is granted may be considered provisional, and a company may be required to complete additional clinical studies that formally demonstrate patient benefit.