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OMB OKs Info on Dispute Resolution

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on formal dispute ...

FDA Accepts NDA for Arthritis Combo Drug

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FDA accepts a Pozen NDA for Vimovo (enteric-coated naproxen and immediate-release esomeprazole magnesium) for treating the signs a...

FDA Approves Valcyte Pediatric Indication

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FDA approves a pediatric indication for and a pediatric oral solution formulation of Roches Valcyte.

FDA Publishes Nonprescription Drug Labeling Guidance

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FDA publishes a guidance to help industry comply with labeling requirements in the Dietary Supplement and Nonprescription Drug Con...

FDA OKs Eurand NDA for Zenpep

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FDA approves a Eurand NDA for Zenpep delayed-release capsules for treating pancreatic insufficiency in patients with cystic fibros...

FDA Questions Lack of Controlled Clolar Trial

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FDA asks the Oncologic Drugs Advisory Committee whether Genzyme should have to conduct a randomized controlled Clolar trial to sup...

FDA OKs Alogliptin CV Outcomes Trial

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FDA approves Takedas EXAMINE study design to determine cardiovascular outcomes for its Type 2 diabetes drug alogliptin.

FDA Orphan Status for Spinal Muscular Atrophy

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FDA grants Families of Spinal Muscular Atrophy an orphan drug designation for quinazoline495 for treating spinal muscular atrophy.

Neuropsychiatric Events Added to Leukotriene Inhibitor Labeling

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FDA says labeling for four leukotriene inhibitors has been updated to include postmarketing reports of neuropsychiatric events in ...

FDA Clears Expanded Labeling on CAS Medical Oximeter

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FDA clears a CAS Medical Systems 510(k) to expand the labeling for its Fore-Sight cerebral oximeter.