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BIMO: Progress Made In 2005 As Violation Rates For Clinical Trials Drop

This article was originally published in The Silver Sheet

Executive Summary

COMPLIANCE WITH FDA CLINICAL TRIAL REGULATIONS appears to be on the upswing as CDRH’s bioresearch monitoring program works to extend help to device manufacturers, division officials say. Out of 332 inspections performed in 2005, only 15% were tagged as being noncompliant, a drop from the 2004 violation rate of 24%. “Companies are doing their job,” says BIMO Director Michael Marcarelli. “This is going to go a long way to improving public confidence.” However, violation rates for institutional review boards continue to climb, and the overall device clinical trial compliance rate still lags behind rates for drug and biologics trials. Meanwhile, a Diagnostic Products Corp. exec tells how his company worked to remove itself from FDA’s “application integrity policy” list – a designation that freezes a firm’s application process...
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