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Mylan files suit against FDA over the agencys refusal to approve its ANDA for a generic copy of Novartiss Diovan (valsartan).[ Price : $8.95]
In a rare display of strategic unity, generic and innovator drug manufacturers make common cause of enhancing supply chain securit...[ Price : $8.95]
During an annual advertising and promotion enforcement update, CDER Office of Prescription Drug Promotion (OPDP) director Tom Abra...[ Price : $8.95]
FDAs Ophthalmic Devices Panel votes to recommend approval for Second Sight Medical Products Argus II Retinal Prosthesis.[ Price : $8.95]
An FDA-funded study examines the lack of children enrolled in clinical trials.[ Price : $8.95]
FDA provides Cleveland BioLabs meeting minutes from a recent end-of-Phase 2 meeting and an advice letter that provides further cla...[ Price : $8.95]
CDER releases a draft guidance entitled Initial Completeness Assessments for Type II API DMFs 2 Under GDUFA to help holders of Typ...[ Price : $8.95]
FDA approves NextWave Pharmaceuticals Quillivant XR extended-release liquid methylphenidate for treating attention deficit hyperac...