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Yaupon Therapeutics NDA for Mechlorethamine

[ Price : $8.95]

FDA accepts for filing a Yaupon Therapeutics NDA for its proprietary gel formulation of mechlorethamine hydrochloride, indicated f...

FDA Clears Bioness Hand Rehab System

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FDA clears a Bioness 510(k) for its NESS H200 Wireless Hand Rehabilitation System.

CDRH Wants Outside Expert Help

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CDRH says it wants comments on a proposal to create a Network of Experts to provide quick staff access to specific specialized kno...

Combined Hormonal Contraceptive Study Results Due

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FDA says a 12/8 joint meeting of two advisory committees will discuss final results from an agency-funded study of cardiovascular ...

Drop Ultrasound Contrast Boxed Warning: Experts

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The International Contrast Ultrasound Society petitions FDA to remove Boxed Warnings from labeling for ultrasound contrast agents.

Wall St. Revolt Has a Warning for FDA and its Industries

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FDA Webview editor Jim Dickinson sees a timely warning for FDA and its regulated industries in the anti-corporate America movement...

Guidance on Device De Novo Classification

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Federal Register Notice: FDA releases a draft guidance on the device de novo classification process or the evaluation of the autom...

FDA Proposes 'Tweaks' to Enforcement Data Transparency

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FDA publishes eight draft proposals under its ongoing transparency initiative that would make minor tweaks to make compliance and ...

FDA Clears Siemens Wireless X-ray System

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FDA clears a Siemens Healthcare 510(k) for the Mobilett Mira, the company's first mobile digital X-ray system with a wireless dete...

CDRH Highlights Regulatory Science Efforts at Center

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A new CDRH report on regulatory science outlines how it fits in at the device Center.