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FDA Has New Device to Detect Counterfeit, Bad Products

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FDA unveils a new, agency developed and manufactured hand-held device, employing LED technology, for rapid identification of count...

QS Violations Found at bioMerieux Facility

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FDAs Atlanta District Office warns bioMerieux about Quality System violations in its Durham, NC, diagnostic device manufacturing f...

FDA Says Lancome Marketing Unapproved Drugs

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FDA warns Lancome USA that many products sold through its Web site are considered drugs that dont have agency approval.

FDA Lymphoseek Complete Response Letter

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FDA issues a complete response letter for Navidea Biopharmaceuticals Lymphoseek NDA.

Annual Device Imports Now Equal 8 Million Line Items: FDA

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CDRH Office of Compliance branch chief Daniel Walter says imported medical devices and related components continue to increase and...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Apia Enterprise, bioMerieux, Generic Medical Devices, Global Biotechnologies, Gr...

MDR Concerns at Kimberly-Clark Plant

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FDAs Atlanta District Office warns Kimberly-Clerk about Medical Device Reporting violations at its Roswell, GA, manufacturing faci...

FDA Boosts its Ability to Handle Large Health Emergencies

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FDA tells science writers that the past two years have brought a dramatic increase in the agencys ability to respond to public hea...

FDA, Cold Genesys Agree on Bladder Cancer Drug SPA

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FDA and Cold Genesys reach agreement on a special protocol assessment for a Phase 2/3 trial of the companys CG0070 for non-muscle ...

Merck Presents New Data on Insomnia Drug

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Merck presents new data from its Phase 3 safety and efficacy trial of its investigational insomnia drug suvorexant.