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Data Integrity Delays: Another Key Takeaway from Ketek

This article was originally published in RPM Report

Executive Summary

Senator Grassley wants FDA to withhold NDAs from advisory committees if there are pending questions about the authenticity of any of the clinical data. The agency appears to agree. That could represent another roadblock to NDA reviews.

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Open Disputes at FDA Advisory Committees: Get Ready for Institutionalized Cacophony

Recent FDA advisory committees on Avandia and Ketek have featured conflicting points of view from FDA internal staff. Get ready for more public airings in the future. Influential Iowa Republican Senator Charles Grassely is directing FDA to bring all opinions into the open.

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