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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Suggestions for Elemental Impurities Draft Guidance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Three stakeholders suggest changes to an FDA draft guidance on elemental impurities in drug products.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...

Panel to Discuss Dynavax Hepatitis B Vaccine

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Federal Register Notice: FDA plans a meeting of the Vaccines and Related Biological Products Advisory Committee 11/16 to discuss a...

FDA Plans Small Business Device/Drug Education Conference

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Federal Register Notice: CDER and CDRH plan a conference 9/27-28 entitled: FDA Small Business and Industry Assistance Regulatory E...

Panel to Discuss 2 NDAs for Pneumonia

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Federal Register Notice: FDA plans a meeting of the Antimicrobial Drugs Advisory Committee 11/4 to discuss two Cempra Pharmaceutic...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Amniotic Therapies, Browns Compounding Center, Central Admixture Pharmacy Servic...