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Distributors Seek Supply Chain Enforcement Discretion

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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...

Pozen Gets 2nd Complete Response Letter on Yosprala

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FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, ...

FDA Clears Sorins Memo 3D ReChord Annuloplasty Ring

[ Price : $8.95]

FDA clears Sorin Groups Memo 3D ReChord annuloplasty ring for mitral valve repair.

FDA Grants Priority Status for Gastrointestinal Sealant

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FDA grants priority review for Cohera Medicals Sylys Surgical Sealant to help reduce anastomotic leakage in gastrointestinal proce...

FDA Approves Cerus Plasma Pathogen Reduction Device

[ Price : $8.95]

FDA approves a Cerus Corp. BLA for its Intercept Blood System for plasma, a pathogen reduction system for reducing the risk of tra...