Chart: The Fast And The Fewer: FDA's Approval Actions Rise As The Number Of Applications Drop

The Fast And The Fewer:
FDA's Approval Actions Rise As The Number Of Applications Drop

The Center for Drug Evaluation and Research's recent annual report shows that approval actions for standard new and expanded use applications reached 83 percent in 2007 compared to 74 percent the year before. The agency approved 91 of 109 submissions - 86 reviews of drugs and five reviews of biologics. The median review time was 10 months with the time to approval at just under a year. CDER approved 75 percent of New Molecular Entities on first-cycle review in 2007, off-setting the record low number of NMEs approvals ('The Pink Sheet,' Jan. 14, 2008, p. 3).