Data Integrity Delays: Another Key Takeaway from Ketek
This article was originally published in RPM Report
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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One leading indicator of a more enforcement-minded approach at the Food & Drug Administration may be a crackdown on clinical trial investigators suspected of fraud. One thing is already clear: sponsors who rely on investigators who trigger suspicions will pay a price in the form of an even tougher time getting the drug through FDA.
The Food & Drug Administration is listening to Capitol Hill about clinical trial data. The agency knows that both critics and defenders of the drug industry want it to ensure the credibility and integrity of clinical trial sites. Sponsors face another source of NDA delays.
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.