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Appeals Court Affirms Bayer Whistleblower Award

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A federal appeals court affirms most of an Arkansas federal jury award to a Bayer Corp. sales representative who was allegedly fir...

Electronic Format Guidances Out

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FDA issues its first two guidances implementing new legal provisions relating to regulatory submissions in electronic format.

FDA Clears ReFlows SpeX Shapeable Support Catheter

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FDA clears a ReFlow 510(k) for its SpeX Shapeable Support Catheter for use in the peripheral vasculature.

2 Charged with Murder in NECC Compounding Rx Deaths

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The federal government charges New England Compounding Center (NECC) and head pharmacist Barry J. Cadden and supervisory pharmacis...

Distributors Seek Supply Chain Enforcement Discretion

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HDMA asks FDA to exercise enforcement discretion for at least three months after the 1/1/15 implementation date for data transfer ...

Veloxis Sues FDA to Force Approval of Envarsus XR

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Veloxis Pharmaceuticals files suit against FDA seeking an order requiring the agency to grant final approval to Envarsus XR (tacro...

Apotex Seeks Approval of Neulasta Biosimilar Product

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FDA accepts for review an Apotex submission for a biosimilar version of Amgens Neulasta (pegfilgrastim), indicated for boosting wh...

Court Nixes FDA Generic Celebrex Exclusivity Decision

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The 4th Circuit Appeals Court rejects the FDA bundle of rights theory that held that original and reissued patents are just one pa...

Senators Question FDA Animal Antibiotic Authority

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Sens. Warren, Feinstein, and Gillibrand ask the secretaries of HHS, Agriculture, and Defense questions about FDAs authority to mon...

Hamburg Touts FDA Steps on Compounded Drugs

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FDA commissioner Margaret Hamburg says the agency is moving forward on several fronts to prevent a repeat of contaminated compound...