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Spine Wave 'PEEK Spacer' Cleared by Agency

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FDA clears a Spine Wave 510(k) for the StaXx XDL Expandable Device, a PEEK (polyetheretherketone) spacer for use in spinal surgeri...

FDA Asks for More Data on Ilaris in Gout Patients

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FDA sends Novartis a complete response letter on a BLA for Ilaris (canakinumab) and its use in gouty arthritis patients.

Mylan Sued On Proposed Generic Orapred

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Shionogi Pharma and Cima Labs file a patent infringement suit against Mylan Pharmaceuticals over an ANDA it submitted for a generi...

Changes are Coming in FDA Field Capabilities

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Consulting editor John Scharmann reports on current expansion of FDAs field staff and investigational capabilities.

FDA Safety Alert for Anzemet Injection

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A new FDA drug safety alert says Sanofi-Aventis Anzemet (dolasetron mesylate injection) should no longer be used to prevent nausea...

FDA Approves Medtronic's Cardiac CryoAblation System

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FDA approves Medtronic's Arctic Front Cardiac CryoAblation Catheter system for use in treating drug refractory paroxysmal atrial f...

FDA Seeks More Data Analysis on AstraZeneca's Brilinta

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FDA sends AstraZeneca a complete response letter on its NDA for Brilinta (ticagrelor), requesting an additional analysis of clinic...

Comments Sought on New Drug Applications

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Federal Register Notice: FDA seeks comments on Application for FDA Approval to Market a New Drug.

Akhigbe Debarred

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Federal Register Notice: FDA issues an order debarringn Ehigiator O. Akhigbe from providing services to a person with an approved ...

Public Citizen Analyzes Recent Pharma Settlements

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A new Public Citizen analysis finds a marked increase in both the number of government settlements with pharmaceutical companies a...