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US FDA's Stellar Drug Review Performance Is Straining Workforce

This article was originally published in SRA

Executive Summary

The US Food and Drug Administration's stellar performance in meeting review goals comes at a cost of "a lot of strain behind the scenes," Office of New Drugs director John Jenkins told the FDA/CMS Summit in Washington, DC, on Dec. 14 - an audience that included stakeholders involved in negotiating the next round of the Prescription Drug User Fee Act (PDUFA VI).

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