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Guidance on Developing Drugs for Otitis Media

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Federal Register Notice: FDA releases a guidance, Acute Bacterial Otitis Media: Developing Drugs for Treatment.

Takeda, Lundbeck File Antidepressant NDA

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Takeda Pharmaceuticals and Lundbeck submit an NDA to FDA seeking approval for vortioxetine for treating major depressive disorder ...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Andes Natural Skin Care, Arkadiy Kisin/White Forest Solutions, Canadadrugs, EMG ...

Device Panel Backs Electronic Eye Prosthesis

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FDAs Ophthalmic Devices Panel votes to recommend approval for Second Sight Medical Products Argus II Retinal Prosthesis.

Children Under-represented in Clinical Trials: Study

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An FDA-funded study examines the lack of children enrolled in clinical trials.

Cleveland BioLabs Meeting Minutes from FDA

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FDA provides Cleveland BioLabs meeting minutes from a recent end-of-Phase 2 meeting and an advice letter that provides further cla...

CDER Guidance on ANDA Type II Drug Master Files

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CDER releases a draft guidance entitled Initial Completeness Assessments for Type II API DMFs 2 Under GDUFA to help holders of Typ...

FDA OKs NextWave Liquid ADHD Medicine

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FDA approves NextWave Pharmaceuticals Quillivant XR extended-release liquid methylphenidate for treating attention deficit hyperac...

Annual FDA Budget Woes Could Become Routine: Alliance

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The Alliance for a Stronger FDA warns that budget woes could be an annual ritual based on the current budget-making process unless...

Genentech Reports Positive Survival Results in HER2-Positive Breast Cancer

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Genentech says a Phase 3 study in HER2-positive metastatic breast cancer patients showed that those treated with trastuzumab emtan...