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FDA Gets 17.5% Funding Boost in Continuing Resolution Agreement

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Congressional negotiators boost FDAs funding by about 17.5% on an annualized basis over FY 2008 available funds under a House-Sena...

Expanding Agency/Sponsor Device Interaction

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AdvaMed says it hopes an FDA guidance on interactive medical device review wont stifle innovative interactions already underway in...

Tarceva Safety Information Updated

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OSI Pharmaceuticals and Genentech say patients with hepatic impairment should be monitored closely when taking Tarceva.

COPD Drugs Linked to Cardio Events

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Researchers say two Boehringer-Ingelheim COPD drugs are associated with an increased risk of cardiovascular events.

FDA Accepts ARCA biopharmas Targeted Heart Failure NDA

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FDA accepts for review an ARCA biopharma NDA for bucindolol, an investigational beta-blocker and vasodilator indicated for treatin...

FDA to Act on Unapproved Papain Products

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Federal Register Notice: FDA plans enforcement action against unapproved topical drug products containing papain due to potentiall...

FDA to Act Against Unapproved Ophthalmic Solutions

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Federal Register Notice: FDA plans enforcement action against unapproved ophthalmic balanced salt solutions for irrigating the eye...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Allez Spine, Mallinckrodt, Omega Supply, and Suarez Corp.

FDA OKs Nasacort AQ for Children Aged 2-5 Years of Age

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FDA approves Sanofi-aventis Nasacort AQ nasal spray for use in children aged two to five years old for treating nasal symptoms ass...

Covidien Quality Control Unit Faulted

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FDAs Kansas City District Office warns Mallinckrodt over cGMP problems at a Covidien Missouri manufacturing facility.