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The New User Fee Rules: FDA Sacrifices Timeliness, Tries to Save Predictability

This article was originally published in RPM Report

Executive Summary

Janet Woodcock is returning as director of CDER at a time when the user fee program is in flux and FDA is struggling to implement new drug safety initiatives. For 2008, timeliness of reviews will slip, but with any luck, the transparency and predictability of PDUFA will continue.

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Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.

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