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FDA releases labeling changes for 27 drugs approved in November, including changes to Contraindication information for three drugs...[ Price : $8.95]
Leaders of the House Energy and Commerce Committee ask FDA commissioner Margaret Hamburg for details about an October cyber securi...[ Price : $8.95]
Baxter International files a BLA for OBI-1, a recombinant antihemophilic porcine sequence factor VIII for treating patients with a...[ Price : $8.95]
FDAs New Jersey District Office warns Ameriderm Laboratories about CGMP violations in its production of drug products.[ Price : $8.95]
FDA warns Sharplight Technologies about regulatory violations in its manufacturing of powered surgical laser instruments.[ Price : $8.95]
A joint FDA advisory committee votes to recommend approval for a Takeda Pharmaceutical BLA for vedolizumab and its use in treating...[ Price : $8.95]
FDAs Seattle District Office warns Jubilant HollisterStier about CGMP violations in its manufacturing of finished pharmaceuticals....[ Price : $8.95]
PhRMA calls on FDA to issue guidance on how drug companies can disseminate healthcare economic data under FDAMA Section 114 withou...