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Confidence, Inc., Drugs, Supplements Seized

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U.S. marshals seize one drug and several dietary supplements marketed by Confidence, Inc.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Advanced Nutritional Technology, Garlic Wise, Global Medical Holdings, Primus Me...

FDA, Mylan Seek Stay on Pioglitazone Shared Exclusivity

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FDA joins a Mylan expedited motion seeking a stay on a 10/22 Washington federal court order to approve a Watson Laboratories ANDA ...

Research Shows Medtronic Resolute Stent Successes

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Medtronic says it has applied to FDA for marketing approval for its 38mm Resolute drug-eluting stent for use in treating long lesi...

FDA Avoids Mission in Meningitis Drug Compounding Tragedy

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As Massachusetts belatedly steps into a void left by FDA in the regulation of high-volume drug compounders, FDA Webview editor Jim...

CDER Improves Backlog of Post-marketing Commitments

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CDER says that 14% of outstanding postmarketing requirements and postmarketing commitments are considered delayed, compared with 1...

Orexigen Encouraged by FDA Dispute Resolution for Obesity NDA

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An FDA response to an earlier Orexigen dispute resolution request indicates that CDER supports further discussions on a potentiall...

FDA Approves Expanded Use for ExAblate Pain Ultrasound

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FDA approves InSightecs ExAblate MRI-guided focused ultrasound as a therapy to treat pain from bone metastases in patients.

Judge Orders FDA to Approve Watsons Generic Actos

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A Washington, DC federal judge sides with Watson Laboratories and sets a judicial precedent by ordering FDA to approve Watson Labo...

Info on Rx Drug User Fee Form Sent to OMB

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Federal Register Notice: FDA submits a collection of information on the prescription drug user fee cover sheet to the Office of Ma...