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Pew, Others Call for Changes to Medical Device Registries

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Three health organizations say that healthcare experts believe there are steps that could be taken to make registries more useful ...

Early Growth Response 1 Gene FISH System into Class 2

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Federal Register Final order: FDA classifies early growth response 1 gene fluorescence in-situ hybridization test system for speci...

Advisors to Look at Testosterone Population, Risks

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FDA says members of its Bone, Reproductive, and Urologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Com...

More Clinical Trial Data Transparency Needed from FDA: Panel

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A House Energy and Commerce Committee roundtable discusses how FDA, industry and Congress should work together to craft legislatio...

Carousel Solutions Inspection Finds QS Problems

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FDAs Seattle District Office warns Carousel Solutions about Quality System Regulation violations in its work as a medical device s...

QS Problems Found at Iradimed

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FDAs Florida District Office warns Iradimed about Quality System and other violations in its manufacturing of MRI infusion pumps a...

All Dermatend Lots Recalled

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FDA says that Solace International is recalling all lots of its Dermatend Original and Ultra in all sizes and dosage forms.

FDA Approves, Denies Parts of Teva Rescue Inhaler Petition

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FDA approves in part and denies in part a Teva April petition asking for a series of agency actions on metered-dose inhalers with ...

CDER Completes Reorganization to Focus on Drug Shortages

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CDER completes a reorganization intended to sharpen the Centers focus and strengthen its resources.

Salix Re-files sNDA for Xifaxan

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Salix Pharmaceuticals files a response to a 2011 FDA complete response letter that rejected a supplemental NDA for Xifaxan (rifaxi...