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Review Period Set for Novartis Coartem

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Federal Register Notice: FDA has determined the regulatory review period for Novartis Coartem (artemether/lumefantrine) is 285 day...

Watson Gelnique Promo in the 'Crapper:' FDA

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FDA cites as misleading a Watson Pharmaceuticals public bathroom promo that was used to promote Gelnique (oxybutynin chloride).

Does FDA Topsides Lack of Transparency Fuel Public Distrust?

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Consulting editor John Scharmann reviews the FDA leaderships increasing lack of transparency and suggests it may be a political co...

Review Period Set for Sanofi-Aventis Multaq

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Federal Register Notice: FDA determines the regulatory review period set for Sanofi-Aventis Multaq for the purpose of patent exten...

Guidance on Public Hearings at Advisory Meetings

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Federal Register Notice: FDA makes available a guidance on the open public hearing at agency advisory committee meetings.

Tobacco Panel to Meet

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Federal Register Notice: FDAs Tobacco Products Scientific Advisory Committee will meet 1/10-11/11 to receive updates.

Sanuwave Health Submits PMA Module to Treat Foot Ulcers

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Sanuwave Health submits to FDA the first module of a PMA for its dermaPACE device for treating diabetic foot ulcers.

Amikacin Shortage, Pontocaine Discontinuation

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FDA posts a Teva Pharmaceuticals shortage of amikacin injection and a discontinuation of Hospiras Pontocaine HCl injection on its ...

FDA Clears Tomophase 510(k) for OCTIS Imaging System

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FDA clears a Tomophase 510(k) to market the Optical Coherence Tomography Imaging System for tissue imaging of airways and lungs.

FDA Looking at Higher Approval Bar for Some Drugs

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CDER Office of New Drugs director John Jenkins says tougher approval standards for diabetes drugs caused by safety concerns associ...