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Federal Register Notice: FDA releases a guidance, Acute Bacterial Otitis Media: Developing Drugs for Treatment.[ Price : $8.95]
Takeda Pharmaceuticals and Lundbeck submit an NDA to FDA seeking approval for vortioxetine for treating major depressive disorder ...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Andes Natural Skin Care, Arkadiy Kisin/White Forest Solutions, Canadadrugs, EMG ...[ 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CDER releases a draft guidance entitled Initial Completeness Assessments for Type II API DMFs 2 Under GDUFA to help holders of Typ...[ Price : $8.95]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...