Zdrowie i gospodarka · 18.11.1998
Guidance for Industry on Fast Track Drug Development Programs: Designation, Development, and Application Review; Availability; Collection of Information
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Fast Track Drug Development Programs: Designation, Development, and Application Review.'' This document provides guidance to industry on FDA's fast track program, which seeks to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs for such conditions. The guidance document is also intended to meet the requirement of section 112(b) of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).