US FDA approvals in 2000 "exceeded virtually all PDUFA performance goals"

The US Food and Drug Administration approved a total of 160 medicationsand medical devices during calendar year 2000, over which time it continued to exceed virtually all its performance goals established under the Prescription Drug User Fee Act, the agency says in a new report.

During fiscal 1999 and 2000, the FDA approved 100% of New Molecular Entities within their PDUFA goal dates, according to the agency, and last year it approved 20 priority drugs in the median time of six months. Moreover, it points out, though PDUFA goals specify review times and not approval times, actual approval times have decreased substantially since the program started. The PDUFA program was originally passed in 1992 and then reauthorized for five more years in 1997.

Increased pediatric-use approvals