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Senators Ask Standards Group for UDI Use

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Sens. Grassley and Warren ask the Accredited Standards Committee X12 for a staff briefing on efforts to include unique device iden...

Appeals Court Backs Lanx in Spinal Device Case Dismissal

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The 5th Circuit Appeals Court agrees with a lower courts grant of summary judgment dismissing claims against Lanx over an implante...

QS, MDR Violations at Simpro

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FDAs Dallas District Office warns Simpro about Quality System, MDR and Web site violations in its importation and distribution of ...

CGMP Violations at 2 Xinxiang Facilities

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FDA warns Chinas Xinxiang Pharmaceutical and Xinxiang Tuoxin Biochemical about CGMP violations in the manufacturing of active phar...

Multiple Violations in Amniotic Therapies Inspection

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FDA warns Amniotic Therapies about multiple violations in its receipt and processing of amniotic tissue from casarean births.

PhRMA Seeks Improved Product Review to Prevent EpiPen-like Events

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Pharmaceutical Research and Manufacturers of America argues that an improved FDA combination product review and approval system co...

California Supreme Court Allows Plavix Suits to be Heard

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The California Supreme Court rules that its state courts have jurisdiction over eight Bristol-Myers Squibb product liability lawsu...

Fewer Cardiovascular Drugs in Trials: Study

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Harvard Medical School researchers identify a number of reasons why fewer cardiovascular drugs have entered clinical trials over t...

Suggestions for Elemental Impurities Draft Guidance

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Three stakeholders suggest changes to an FDA draft guidance on elemental impurities in drug products.

Guidance on Enforcement of NHRIC/NDC Device Codes

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Federal Register Notice: FDA releases a guidance: Enforcement Policy on National Health Related Item Code and National Drug Code N...