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Nominations Sought for Device Panels

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Federal Register Notice: FDA requests nominations for voting members to service on several device advisory committees.

Panel to Vote on NaviStar Catheter

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Federal Register Notice: FDAs Circulatory System Devices Panel will meet 11/20 to discuss Biosense Websters NaviStar ThermoCool ir...

Panel to Discuss Takedas Uloric

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Federal Register Notice: FDAs Arthritis Advisory Committee will meet 11/24 to discuss Takeda Pharmaceuticals NDA for Uloric for tr...

Pediatric Panel to Discuss AERs on 10 Products

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Federal Register Notice: FDAs Pediatric Advisory Committee will meet 11/18 to discuss adverse event reports for 10 drug products.

FDA Hiring Program Meets its Target

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Consulting editor John Scharmann reports that contrary to his prediction, FDAs ambitious plan to hire 1,323 new employees by 9/30 ...

QSR Guidances: Making Law at CDRH in a Deregulatory Era

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Editor Jim Dickinson reports on apparent efforts by CDRHs Kimberly Trautman to use industry meetings to convert draft, voluntary g...

FDA Launches Drug Safety Web Page

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FDA launches the drug safety Web page mandated by the FDA Amendments Act.

Safety Hasnt Made Us More Conservative: Woodcock

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CDER director Janet Woodcock rejects the idea that greater attention to product safety has made FDAs regulatory process more conse...

Troy Was Preemption Guru in Many Agencies: Trial Lawyers

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An American Association for Justice report details how former FDA chief counsel Daniel Troy created the strategy to have many fede...

FDA Sees No Panel Member Conflict with $5 Million Gift

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The $5 million gift provides funding to expand the centers research agenda, such as imports of food and consumer goods from countr...