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FDA Backs Xarelto Safety After Analyses on Faulty Device Used in Trial

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FDA says that internal analyses on the use of Aleres faulty blood testing devices (INRatio and INRatio 2 PT/INR) had a minimal imp...

Yangzhou Hengyuan Had CGMP Problems

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FDA warns Chinas Yangzhou Hengyuan drug manufacturing company about violations of CGMP regulations for finished pharmaceuticals.

CGMP Violations at Genevas Laboratoire Sintyl

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FDA warns Switzerlands Laboratoire Sintyl about CGMP violations in its production of an OTC drug.

Court Rejects Law Firms Risperdal Appeal

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The Third Circuit Court of Appeals agrees with a Pennsylvania federal court that the Sheller law firm lacks standing to compel FDA...

FDA Approves Protein Sciences BLA for Flublok Quadrivalent

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FDA approves a Protein Sciences BLA for its quadrivalent formulation of Flublok influenza vaccine, which protects against four str...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites CFP Acquisitions, Delarange Cosmetics & Healthcare, Laboratoire Sintyl, and Yang...

Court Throws Out 1 New England Compounding Case

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The Massachusetts federal court dismisses a suit against two New England Compounding Center order-checkers that charged them with ...

DeSantis Introduces Reciprocity Bill

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Rep. DeSantis introduces legislation to permit marketing reciprocity for drugs, biologics. And medical devices that are approved i...

FDA Sees Battery Problems in Some St. Jude Devices

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FDA and St. Jude Medical say that batteries on some defibrillators may drain quickly after signaling the patient that the battery ...

Guidance on Sunscreen Advisory Panel Process

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Federal Register Notice: FDA releases a guidance on Sunscreen Innovation Act: Section 586C(c) Advisory Committee Process for panel...