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Adverse Event Reporting Deluge Diagnosed By IRB Reps At FDA Hearing

This article was originally published in The Gray Sheet

Executive Summary

Clinical trial sponsors should assume oversight of safety data that currently burden institutional review boards, participants agreed at an FDA public hearing on adverse event (AE) reporting to IRBs

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AdvaMed endorses status quo for IRB regs

Investigational device regulations for devices adequately address reporting of adverse events to Institutional Review Boards and should not be altered if the agency decides to modify drug reporting requirements, AdvaMed maintains in FDL-1April 21 comments to FDA. The comments respond to a March 21 public hearing on AE reporting. At the hearing, participants debated whether IRBs are overburdened by reports from multicenter trials (1"The Gray Sheet" March 28, 2005, p. 25). Such problems are limited to drug trials, and "if FDA feels compelled to address drug-related AE reports to IRBs, AdvaMed believes it could be managed through FDA guidance to drug manufacturers clarifying which drug events are reportable to IRBs," the device trade group concludes...

AdvaMed endorses status quo for IRB regs

Investigational device regulations for devices adequately address reporting of adverse events to Institutional Review Boards and should not be altered if the agency decides to modify drug reporting requirements, AdvaMed maintains in FDL-1April 21 comments to FDA. The comments respond to a March 21 public hearing on AE reporting. At the hearing, participants debated whether IRBs are overburdened by reports from multicenter trials (1"The Gray Sheet" March 28, 2005, p. 25). Such problems are limited to drug trials, and "if FDA feels compelled to address drug-related AE reports to IRBs, AdvaMed believes it could be managed through FDA guidance to drug manufacturers clarifying which drug events are reportable to IRBs," the device trade group concludes...

FDA Eyes Changes To IRB Adverse Event Reporting; March Meeting Planned

Device manufacturers and other stakeholders will have an opportunity next month to discuss ways that reporting adverse events to institutional review boards can be improved

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