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Singulair and Lipitor Most Prescribed Drugs

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The Agency for Healthcare Research and Quality says Singulair and Lipitor were the most prescribed drugs in 2004.

FDA Clears Vision-Sciences Endoscope Line

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FDA clears Vision-Sciences ENT and TNE digital video endoscopes.

FDA Panel Votes Against New Limits on Anemia Drugs

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An FDA advisory committee votes not to recommend new limits on the use of erythropoeisis-stimulating agents (ESA) marketed by Amge...

State Looking Into Genetic Test Ads

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Connecticut attorney general Richard Blumenthal investigates Myriad Genetics DTC ads touting a test for genetic mutations that inc...

Concern Rising, But Foreign Inspections on the Decline

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In a wide-ranging discussion of issues in FDA foreign inspections, former CBER compliance director Mark Elengold provides data sho...

Physicians Urge Strict Conflict-of-Interest Rules for Panels

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Nine prominent physicians write Senators Edward M. Kennedy (D-MA) and Christopher J. Dodd (D-CT) asking them to adopt a House-pass...

FDA Updates List of Standards

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Federal Register Notice: FDA publishes a list of modifications to recognized device standards.

FDA Removes Portion of Panel Meeting

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Federal Register Notice: FDA amends the notice of the 10/16 Cardiovascular and Renal Drugs Advisory Committee to remove the discus...

Panel to Discuss Medtronic Stent System

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/10-11 to discuss a Medtronic PMA for the Endeavor Zota...

Antidepressant Suicide Warnings in Label Changes

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Among many July labeling changes, FDA approves boxed warnings for nine antidepressants cautioning against increased risk of suicid...