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Do Better Advisor Recruiting: GAO

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The Government Accountability Office suggests FDA expand its search criteria for advisory committee members without potential conf...

OvaSure Marketed Without Approval

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CDRH warns Laboratory Corporation of America that it does not have agency approval for its OvaSure test.

FDA Clears Neuro-stimulation Device for Depression

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FDA clears a Neuronetics 510(k) for the NeuroStar TMS (Transcranial Magnetic Stimulation) Therapy system, intended for use in trea...

FDA Posts Sunquest Information Systems Device Correction

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Sunquest Information Systems initiates a medical device correction on software used with its Sunquest Laboratory Blood Bank and Bl...

Kids Cold Drug Labeling is Political Compromise

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Public Citizens Peter Lurie says the industry decision to raise the age restriction for kids cold and cough drugs was political ra...

FDA OKs Chembio HIV Tests for Use in Younger Population

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FDA approves a Chembio Diagnostics PMA supplement for its HIV rapid point-of-care tests for use in individuals 13 years of age and...

Dingell Probes FDA Role in Actavis Recalls

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Reps. Dingell and Stupak raise questions about FDAs handling of cGMP problems at Actavis manufacturing facilities.

Suit Charges Pfizer Manipulated Neurontin Trials

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A new lawsuit charges that in addition to marketing Neurontin for off-label indications, Pfizer manipulated clinical trials and pu...

FDA Approves Akorn NDA for Ophthalmic Anesthetic

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FDA approves an Akorn, Inc. NDA for Akten (lidocaine) ophthalmic gel 3.5%, a topical anesthetic indicated for use in ocular proced...

FDA Approves Advanced Medical Optics PMA

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FDA approves an Advanced Medical Optics PMA for the Healon D viscoelastic, an ophthalmic viscosurgical device intended for use as ...