NDA median approval time is shortened by 7% to 15.4 months in 1996.
Executive Summary
FDA 1996 MEDIAN NDA APPROVAL TIME OF 15.4 MONTHS IS 7% FASTER than the 1995 median time of 16.5 months, according to an analysis of 1996 review data released by FDA on Jan. 14. FDA approved 131 NDAs in 1996, a 60% increase over 1995's 82 NDAs. With eight biological approvals bringing the total number of new products approved to 139, FDA approved 63% more drugs and biologicals in 1996 than in 1995, when 85 new products were approved.You may also be interested in...
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