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FDA Clears Onset Medical Catheter

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FDA clears an Onset Medical 510(k) for the SoloPath TransFemoral Endovascular Access Catheter.

FDA Accepts Pain Patch NDA for Review

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FDA accepts for review a NeurogesX NDA for NGX-4010, indicated for managing pain related to post-herpetic neuralgia.

15 Boxed Warnings in Labeling Changes

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FDA announces October labeling changes including boxed warnings for 12 antibiotics on tendenopathy and tendon rupture.

King Submits NDA for Imaging Agent

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King Pharmaceuticals submits an NDA for CorVue (binodenoson) for injection, a cardiac pharmacologic stress imaging agent intended ...

FDA OKs New Dosing for Anthrax Vaccine

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FDA approves an Emergent BioSolutions supplemental BLA for its BioThrax (anthrax vaccine adsorbed), which provides for a change in...

Novartis Gleevec OKd to Prevent Recurrence of Rare Cancer

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FDA approves Novartis Gleevec for another new indication retarding cancer growth in patients following surgical removal of a gast...

Sun Med Recalls Laryngoscope Blades

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Sun Med recalls laryngoscope blades because a piece of the acrylic light tube may break off during the procedure.

Why is There a Taint When Good Works Get Industry Support?

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FDA Webview editor Jim Dickinson reviews public rebukes for exposing, and not exposing, the money that good works have long receiv...

Amgen Submits Denosumab BLA

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Amgen files a BLA with FDA for its denosumab seeking indications for postmenopausal osteoporosis and bone loss in prostate and bre...

FDA Wants Ustekinumab REMS

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FDA asks Centocor for additional information on its BLA for ustekinumab, including a Risk Evaluation and Management Strategy.