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FDA, AdventRx Meet on Rejected Bio Study

[ Price : $8.95]

AdventRx says a recent meeting with FDA on an August complete response letter for Exelbine (vinorelbine injectable emulsion) conf...

Chembio Diagnostics PMA Module for HIV Test

[ Price : $8.95]

Chembio Diagnostics files a second PMA module for its DPP HIV 1/2 Assay which contains non-clinical data for the product.

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

[ Price : $8.95]

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.

Sometimes, Should FDA Consider Product Cost?

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FDA Matters author Steven Grossman argues that in some cases FDA should consider the cost difference between an expensive product ...

FDA Clears Nucletron's Brachytherapy Device

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FDA clears a Nucletron 510(k) clearance for its new Vaginal CT/MR Multi Channel Applicator, a brachytherapy solution that enables ...

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Federal Register Notice: FDA releases a draft guidance on the device de novo classification process or the evaluation of the autom...

Want to Save Thousands of Lives, Dr. Hamburg?

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Washington commentator Robert F. Steeves challenges commissioner Hamburg to take two easy steps that he says would save thousands ...