FDA Accelerates Its Approval of New Drugs.(Brief Article)

Chemical Market Reporter, February, 1999 by HESS, GLENN

THE FOOD AND DRUG Administration's Center for Drug Evaluation and Research reviewed 199 new drug applications in 1998 and approved 90 of them, according to an FDA performance report. The average review time by the FDA department in 1998 was 12 months, down from 14.4 months in 1997. Last year, 25 priority drugs, considered to be of "potentially exceptional public health value," were approved in a median time of 6.4 months.

Six high-priority drugs were approved in six months or less, including the AIDS drugs efavirenz, which was approved in just 3.2 months, and fomivirsen, which was approved in 4.6 months. The impotence drug sildenafil (Viagra) was approved in 5.9 months. Capecitabine, an oral cancer drug; rifapentine, the first new tuberculosis...

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