A change in the Food and Drug Administration's "philosophy toward review of applications" is responsible for a "remarkable" acceleration in the time required for new drug approvals, according to Kenneth I. Kaitin, director of Tufts University's Center for the Study of Drug Development. The result has been an upsurge of novel medications on the market in recent years. Kaitin adds that the agency and industry now are turning their joint efforts toward shortening drug development times, particularly clinical trials.
The payment of user fees to FDA by drug developers for improvement of review efforts has been central to the success, says Kaitin, whose group has been publishing triennial reports on new drug approvals for 15 years. User fees were instigated by a 1992 federal law, then renewed in the 1997 Food and Drug Administration Modernization Act (FDAMA). Provisions in the latter law, some of which are still to be...
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