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FDA Accepts Takeda/Lundbeck NDA for Brintellix

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FDA accepts for review a Takeda and H. Lundbeck NDA for Brintellix for treating major depressive disorder in adult patients.

Advisors Asked About Drug Teratogenic Risk

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FDA releases discussion points on managing drug teratogenic risk for a rescheduled meeting of the Drug Safety and Risk Management ...

CDER Staff Worried About Late-Cycle Meetings: Jenkins

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CDER Office of New Drugs director John Jenkins says his staff are worried about the outcomes from the addition of late-cycle meeti...

FDA Approves Sucampo sNDA for Rescula

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FDA approves a Sucampo Pharmaceuticals supplemental NDA for Rescula 0.15% for lowering intraocular pressure in patients with open-...

FDA Releases Celltex Therapeutics Inspection Results

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FDA releases the FDA-483 containing 14 inspection observations issued after an April inspection at Celltex Therapeutics.

Info on Device Pre-submission Meetings Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on a guidance on ...

FDA Debars Knott

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Federal Register Notice: FDA debars Susan F. Knott for two years from providing services to any person with an approved or pending...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites GC America, The Judge Rotenberg Educational Center, MedArt A/S, Parks Medical El...

Managing Medical Devices on IT Networks Top Challenge: Survey

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Survey results from healthcare technology management professionals say their biggest challenge is managing medical devices and sys...

Consumers See Disease Risk in Cheaper Life-saving Drugs

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A Journal of Consumer Research study finds that drug prices affect how much risk consumers think they have of contracting the dise...