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Stakeholders Ask High Court Apotex Hearing

[ Price : $8.95]

Fish & Richardson attorneys review two amicus briefs urging the Supreme Court to hear Apotex biologics law appeal against Amgen an...

FDA Seeks OMB Approval for DTC Study

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Federal Register Notice: FDA seeks comments on a planned direct-to-consumer (DTC) advertising study that has been submitted to OMB...

Workshop Planned for Improving Hospital Device Surveillance

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Federal Register Notice: FDA announces a 12/5 public workshop on The Role of Hospitals in Modernizing Evidence Generation for Devi...

CGMP Violations at Czech Interpharm

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FDA warns the Czech Republics Interpharm about CGMP deviations and violations in its production of active pharmaceutical ingredien...

CGMP Violations at Teva Godollo, Hungary, Plant

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FDA warns Teva about CGMP violations at its Godollo, Hungary, finished pharmaceuticals plant.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Buderer Drug Company, Colabs International, Diamond Wipes International, ITW PRO...

St. Jude Recalls 250,000 Defibrillators

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St. Jude Medical recalls certain models of its Fortify, Unify, and Assura implantable cardioverter defibrillators and cardiac resy...

More Info Sought on Ulcerative Colitis Guidance

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Six drug companies say that additional information on various issues is needed in an FDA draft guidance on clinical endpoints for ...

Class-wide Label Warning for Testosterone

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FDA approves a class-wide labeling change for all prescription testosterone products, adding a new Warning and updating the Abuse ...

Petition to Amend External Analgesic Drug Monograph

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Metabolic Therapy asks FDA to revise its external analgesic drug products monograph to indicate that such products containing mela...