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Adverse reaction forms

This article was originally published in The Tan Sheet

Executive Summary

Public Citizen's Health Research Group urges FDA in April 12 comments to delay development of a common reporting form for adverse incidents involving drugs, medical devices and biologics. HRG recommends that FDA first conduct a six-month field study comparing the effectiveness of the new form to existing forms. HRG asserts that new forms "should be adopted only after the agency has sufficient evidence that they will improve compliance among mandatory and voluntary reporters." FDA currently is in the process of developing an adverse drug reaction reporting system for OTCs.
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