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FDA Issues 1 New, 4 Updated Medication Guides

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FDA issues five new or updated Medication Guides.

Group Takes FDA Back to Court Over Foot-Dragging

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The Center for Reproductive Rights files a motion for contempt over FDA's alleged delay in complying with a federal court order to...

More Consumers Turning to Internet for Medical Advice

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An Accenture survey finds that only 11% of consumers seeking health information online turn to drug company Web sites most often.

Guidance on Mammography Quality Regulations

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Federal Register Notice: FDA releases a guidance on modifications and additions to the Mammography Quality Standards Act regulatio...

Workshop on Improving Defibrillators

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Federal Register Notice: FDA plans a public workshop 12/15-16 to promote next-generation safer and more effective external defibri...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Ascension Orthopedics, The Boppy Co., Nexgen Pharma, Pega Medical, Sepal Reprodu...

FDA Reviewers Question MelaFind Safety, Effectiveness

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FDA medical device reviewers bluntly say they believe that Mela Sciences MelaFind could do more harm to the public health than goo...

Hospitalized Beneficiaries Experience Adverse Events

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An HHS report says the U.S. continues in a patient safety crisis for hospitalized patients that must be addressed by federal agenc...

FDA Panel Backs Lupus Drug

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FDA's Arthritis Drugs Advisory Committee votes 13-2 to recommend approval of Human Genome Sciences' lupus drug Benlysta.

FDA Approves Impax ANDA for Generic Allegra

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FDA approves an Impax Laboratories ANDA for a generic version of Sanofi-Aventis' allergy drug Allegra-D.