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Talent Squeeze at FDA: Bad News for Drug Reviews, Good News for Merck?

This article was originally published in RPM Report

Executive Summary

FDA's drug review managers and staff are showing signs of wear and tear from the tough political climate for the agency. Some key staff have departed. Merck took advantage of the turmoil to get a manager with knowledge of the endocrine area, where the taranabant NDA will be filed.

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FDA is in the midst of a hiring frenzy to rebuild a severely understaffed agency. The good news is that the center for drugs is about halfway through the process, with the Office of New Drugs receiving the bulk of new hires. It's not equal across review divisions-some are receiving more new people than others.

Reinforcements At Last: CDER Hiring Process Well Underway

FDA is in the midst of a hiring frenzy to rebuild a severely understaffed agency. The good news is that the center for drugs is about halfway through the process, with the Office of New Drugs receiving the bulk of new hires. It's not equal across review divisions-some are receiving more new people than others.

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