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FDA Changes Its Mind On Vytorin; Ads Must Note “Efficacy Limitation”

Executive Summary

One of the more interesting revelations from the House Energy and Commerce Committee's investigation into the ENHANCE trial is a document that may help explain why the Vytorin TV ads were pulled - and how FDA is handling questions about product efficacy in the current environment

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Business News, In Brief

Novo Nordisk and Allergan both report setbacks during their respective first quarter earnings calls. Meanwhile, Valeant and Actavis avoid speculation about a potential merger, and other Q1 happenings.

Drug Safety Vacuum In Congress? Rep. Stupak To Leave After This Term

Michigan Democrat's departure leaves opening at top of House oversight panel where his investigations included Merck's handling of unfavorable Vytorin study results and FDA's approval of Ketek.

GAO Questions FDA's Handling Of Surrogate Endpoints

FDA should develop guidance delineating when it would withdraw products that have been cleared under the accelerated approval mechanism, according to a report from the Government Accountability Office

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