Guidance for Industry. Fast Track Drug Development Programs: Designation, Development and Application Review

摘要

The fast track programs of the Food and Drug Administration (FDA) are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs (fast track products). This document provides guidance to industry on FDA's fast track programs and, in doing so, is intended to meet the requirement of section 112(b) of the Food and Drug Administration Modernization Act of 1997.