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Welch Allyn Defibrillators Recalled

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FDA says a Welch Allyn AED 10 defibrillator recall is a Class 1 recall.

Bayer Suspends Trasylol Marketing Amid Safety Concerns

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Bayer suspends marketing of blood loss drug Trasylol (aprotinin) amid growing safety concerns after a Canadian trial is stopped du...

Device Wholesaler Must Wear FDCA Violator Shirt

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A federal judge sentences an Alabama medical device wholesaler to wear a shirt reading I was convicted of violating the FDCA.

Global Drug Market to Grow 5-6%

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IMS Health forecasts slightly lowered growth in the global pharmaceutical market next year.

FDA 3-month Extension on Regereron BLA

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FDA extends by three months a Regeneron Pharmaceuticals BLA action date for for Rilonacept (interleukin-1) trap), indicated for tr...

Barr Submits ANDA for Generic Ritalin

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Barr Pharmaceuticals submits an ANDA seeking approval for a generic copy of Novartis Ritalin LA.

Statprobe Fraud Case Can Go to Trial

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Federal judge Gene Pratter says a woman can continue her suit charging contract research organization Statprobe with negligence an...

Tentative Approval on Ciplas Generic Zerit

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FDA tentatively approves a Cipla Ltd ANDA for a generic copy of Bristol-Myers Squibbs Zerit (stavudine), indicated for treating pe...

FDA Seeks Recall of Drug-containing Supplements

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FDA asks America True Man Health Inc. to recall all True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men'...

Feds Warn About Cleaners Around Electronic Equipment

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FDA and other federal agencies issue a public health notification on avoiding hazards associated with using cleaners and disinfect...