Independent Evaluation of the Food and Drug Administration's First Cycle Review Performance-Retrospective Analysis Final Report; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a report entitled "Independent Evaluation of FDA's First Cycle Review Performance--Retrospective Analysis Final Report." This report describes an independent evaluation of the issues associated with FDA's conduct of first cycle reviews of new molecular entities for new drug applications (NMEs for NDAs), and biological license applications (BLAs). Applications covered by the report are those submitted to FDA in fiscal years 2002 to 2004. This independent study was conducted in relation to the Prescription Drug User Fee Amendments of 2002 (PDUFA III). This assessment includes a detailed evaluation of the events that occurred during the review process with a focus on identifying the best practices by FDA and industry that facilitated that process.