Analysis and overview of new drug reviews from 1993 through present by an over 20-year-active FDA veteran of drug approvals, Dr. John Jenkins (Director, Office of New Drugs, Center for Drug Evaluation and Research). The presentation includes review times and comparison to global approvals. Of note, median approval times for New Molecular Entities (NME) applications are 10 months, a 47% reduction from calendar year 1993. A status update on CDER compliance with past PDUFA goals is given, with information on forward planning to comply with PDUFA V goals. In accordance with the enhanced emphasis on benefit-risk analysis in PDUFA V, discussion of the anticipated framework and balance of stakeholder concerns is detailed. The PDUFA V program for NME review is presented, with key elements and projected timelines detailed.
This slide presentation gives excellent perspective of past and future trends for the global pharmaceutical market, with emphasis on FDA approvals of NME.
Source Slide Show (pdf hyperlink): FDA