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FDA classifies as Class 1 a recall by Insulet Corp. of its OmniPod Insulin Management System due to insulin delivery issues.[ Price : $8.95]
FDA issues a guidance describing the factors it considers in taking regulatory action against animal drug distributors whose label...[ Price : $8.95]
Stakeholders offer suggestions for improving an FDA draft program to expedite access to innovative medical devices.[ Price : $8.95]
FDA grants Takeda Pharmaceutical Co. a priority review for its NDA for ixazomib, the first investigational oral proteasome inhibit...[ Price : $8.95]
Ropes & Gray attorneys outline the FDA draft guidance on biosimilar naming and questions that are left unanswered pending public c...[ Price : $8.95]
Pacira asks a New York federal court to overturn an FDA Warning Letter preventing the company from making truthful, non-misleading...[ Price : $8.95]
FDA approves a New Haven Pharmaceuticals NDA for Durlaza (aspirin), a 24-hour, extended release capsule (162.5mg) formulation for ...[ Price : $8.95]
CVM announces fees for animal food and feed ingredients export certificates effective 10/1.