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FDA commissioner speculation focuses on Henney's possible reprise of PDUFA role.

This article was originally published in The Tan Sheet

Executive Summary

PDUFA II: WILL EX-FDA DEPUTY COMMISSIONER HENNEY REPRISE her role in the implementation of new prescription drug user fee application review programs at FDA? With the delay in the appointment of a permanent successor to FDA Commissioner David Kessler, MD, the restless audience of Washington FDA watchers has begun to speculate on a sequel appearance for Jane Henney, MD, to implement the new user fee provisions and to manage the initial requirements of the FDA Modernization Act, signed into law Nov. 21. During her previous stint at FDA, Henney was one of the senior agency officials overseeing implementation of the 1992 Prescription Drug User Fee Act.
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