PDUFA report card

WASHINGTON - FDA issued its internal report card on review times and numbers of products approved in 1997 (see Online Links, A4). The Center for Drug Evaluation and Research (CDER) announced that the median time to approve new drugs was 14.4 months in 1997, a 6 percent improvement over 1996. The median CDER review time for new drug applications, including those deemed unapprovable, was 12.2 months, an 18 percent improvement over 1996. All CDER applications are reviewed under user fee guidelines.

New molecular entities accounted for 39 of the 121 new drugs reviewed by CDER...