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FDA Denies Merck Nasonex Petition

[ Price : $8.95]

FDA denies a Merck petition asking that it not accept ANDAs for generic Nasonex.

FDA 6-month Pediatric Exclusivity for Aciphex

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FDA awards Eisai an additional six months marketing exclusivity for Aciphex for meeting criteria under the agencys pediatric exclu...

MDR, QS Violations Found at MedArt

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FDA warns MedArt about Medical Device Reporting and Quality System violations found in an inspection at a company manufacturing fa...

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...

FDA Panel Nixes Zogenix Pain Drug Due to Abuse Potential

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An FDA advisory committee votes 2 to 11 against recommending approval for Zogenix pure hydrocodone pain medication Zohydro ER due ...

Genentech Says Perjeta Extends Survival in Breast Cancer

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Genentech reports that a Phase 3 study shows that Perjeta, Herceptin, and docetaxel extended survival in HER2-positive breast canc...