Lessons from recent history; The PDUFA report

Representatives of the biotechnology and pharmaceutical industries and the FDA have been working hard to meet the agency's deadline on Friday this week on terms for re-authorizing the Prescription Drug User Fee Act. At the same time, the FDA was busy congratulating itself on its performance in approving new drugs, both in its annual performance report to Congress and in a speech by Commissioner David Kessler.

Perhaps unnoticed were two concurrent

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