Definitions for "Accelerated approval"
intended to speed the clinical development and regulatory review of important new medicines through the use of surrogate endpoints to predict the clinical benefit of the treatment
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 are designed to measure and the FDA evaluation is performed on the basis of 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.
A highly specialized mechanism intended to speed approval of drugs promising significant benefit over existing therapy for serious or life-threatening illnesses. It incorporates elements aimed at making sure that rapid review and approval is balanced by safeguards to protect both the public health and the integrity of the regulatory process. This mechanism may be used when approval can be reliably based on evidence of a drug's effect on a "surrogate endpoint" (see "Surrogate Endpoint"), or when FDA determines an effective drug can be used safely only under restricted distribution or use. Usually, such a surrogate can be assessed much sooner than such an endpoint as survival. In accelerated approval, FDA approves the drug on condition that the sponsor study the actual clinical benefit of the drug.