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FDA Consent Decree with Venus Pharmaceuticals

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FDA and dietary supplement maker Venus Pharmaceuticals International enter into a consent decree over repeated GMP violations at t...

Senators Find Questionable Ties Between Medtronic and Doctors

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Sens. Baucus and Grassley say Medtronic never disclosed that it paid millions of dollars to physicians to write and edit journal a...

Appeals Court Affirms Preemption in Generic Reglan Case

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A federal appeals court affirms a lower courts decision to dismiss a state product liability lawsuit based on preemption arguments...

Synthetic Botanicals Can Be Dietary Ingredients: CRN

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The Council for Responsible Nutrition calls on FDA to reverse its stand that synthetic botanical constituents cant be dietary ingr...

FDA Wins Injunction Against Herb/Supplement Maker

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FDA wins a permanent injunction against Truman J. Berst, doing business as Alternative Health & Herbs Remedies (Albany, OR) for se...

White Paper on Device Endotoxin Testing

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A new white paper from Microtest Labs assists medical device makers with understanding recent changes to FDAs recommendations for ...

FDA Criminal Probe of CA Lap Band Clinics

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An FDA affidavit in a case involving Lap Band clinics in California says the clinic owners are being investigated for potential vi...

Panel to Discuss REMs and Teratogenic Risk

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Federal Register Notice: FDAs Drug Safety and Risk Management Advisory Committee will meet 12/12 to discuss teratogenic risk, incl...

Public Citizen Wants Independent Probe of FDA Compounding Role

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Public Citizen calls for the HHS Inspector General to investigate FDAs failure to protect the public from the meningitis outbreak ...

Product Approvals Highlight CBER Annual Report

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CBER director Karen Midthun says the Center approved a number of new vaccines and other products during FY 2011.