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More Clinical Trial Transparency Urged

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A Yale professor and co-authors propose making participant-level clinical trial data available for independent analysis to improve...

FDA Seeks Injunction Against Dietary Supplement Firm

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FDA asks for a permanent injunction against a Pennsylvania dietary supplement manufacturer and distributor and their owner.

Medtronic New Glucose Monitor Approved

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FDA approves Medtronics iPro2, a next-generation continuous glucose monitoring system.

CGMP Violations Found at Jenahexal Plant

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FDA warns Jenahexal Pharm about CGMP and other violations in its homeopathic drug manufacturing facility in Germany.

Court Upholds State Failure-to-Warn Decision

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A North Carolina federal judge dismisses Novartis post-trial motions seeking to overturn a jury award of damages in a state law fa...

Mylan Warned About Quality Problems at Caguas

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FDAs San Juan District Office warns Mylan Laboratories about CGMP violations at its Caguas, Puerto Rico, drug manufacturing facili...

FDA Clears Canon Radiography Detectors

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FDA clears a Canon USA 510(k) for the CXDI-80C and CXDI-501 Wireless Digital Radiography Detectors.

Merck Settling Vioxx Civil, Criminal Charges for $950 Million

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Merck says it will pay $950 million to resolve federal and state civil and criminal charges involving sales and marketing of its V...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Altaire Pharmaceuticals, Focus Laboratories, Hub Pharmaceuticals, Jenahexal Phar...

Supercommittees Failure Could be Dire for FDA Budgets

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The Congressional supercommittee's failure this week to come to terms on a deficit reduction plan leaves FDA and other agencies fa...