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Ways to disseminate device safety information considered

This article was originally published in The Silver Sheet

Executive Summary

FDA is scrutinizing ways to release device safety information to the public, seeking to be timely without sacrificing completeness and accuracy. "The historical strategy of waiting to communicate until the end of a lengthy evaluation and negotiation process doesn't work," says Nancy Ostrove, senior advisor for risk communication in FDA's Office of Planning. Patients and doctors want information earlier than ever before, she says, yet risk assessment remains a lengthy and complex process. Consequently, FDA and manufacturers walk a "parallel tightrope," making judgments based on less-than-complete data and deciding how and when to communicate that data to the public. FDA has never systematically analyzed how the public receives and interprets safety information. That task will be the primary mission of the new 15-member Risk Communication Advisory Committee, set to convene for the first time early this year ("The Silver Sheet" November 2007)
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