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FDA Says Clinical Lasers Selling Unapproved Devices

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FDA warns Clinical Lasers about selling laser devices without agency marketing clearance or approval.

QS Violations Found at Ad-Tech

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FDAs Minneapolis District Office warns Ad-Tech about Quality System violations in its manufacture of subdural and depth electrodes...

CDRH Class 1 Recall for Hospira GemStar Pumps

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CDRH classifies as Class 1 a recall involving Hospiras GemStar Infusion System.

CLR Medicals Recalls Viscocel Products

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CLR Medicals International recalls its Viscocel and Viscocel Plus products following an FDA inspection that cited deficiencies wit...

Obama Nominates OCI Head Roth as Homeland Security IG

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President Obama nominates FDA Office of Criminal Investigations director John Roth to serve as inspector general of the Department...

Boxed Warning Required for Hydroxyethyl Starch Products

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FDA says that revised labeling for hydroxyethyl starch solutions highlights risks of mortality and renal replacement therapy.

FDA Committee to Discuss New REMS Methods

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An FDA advisory committee next month meets to identify and discuss new methods for communicating risk information as part of Risk ...

FDA Alerts Medical Community to Bogus Botox

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FDA alerts medical practices about counterfeit Botox being distributed by Online Botox Pharmacy, onlinebotox.com and onlinebotox....

FDA Approves New Noxafil Formulation

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FDA approves Mercks Noxafil 100 mg delayed-release tablets for treating certain patients at high risk for invasive aspergillus and...

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites 23andMe, Inc., Ad-Tech Medical Instrument, Cheen Houng Enterprise, Clinical Lase...