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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 ...[ Price : $8.95]
Veloxis Pharmaceuticals files suit against FDA seeking an order requiring the agency to grant final approval to Envarsus XR (tacro...[ Price : $8.95]
FDA accepts for review an Apotex submission for a biosimilar version of Amgens Neulasta (pegfilgrastim), indicated for boosting wh...[ 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...[ Price : $8.95]
Sens. Warren, Feinstein, and Gillibrand ask the secretaries of HHS, Agriculture, and Defense questions about FDAs authority to mon...[ Price : $8.95]
FDA commissioner Margaret Hamburg says the agency is moving forward on several fronts to prevent a repeat of contaminated compound...[ Price : $8.95]
FDA issues Pozen a second complete response letter (CRL)on its NDA for Yosprala (aspirin and omeprazole) delayed release tablets, ...[ Price : $8.95]
FDA clears Sorin Groups Memo 3D ReChord annuloplasty ring for mitral valve repair.