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New guidance on physician notifications:

This article was originally published in The Silver Sheet

Executive Summary

Manufacturers should alert physicians about newly discovered implantable defibrillator risks before their patients learn about them through the media, FDA recommends in a newly released guidance document. The recommendation is one of six "best practices" identified in the document, "Writing Dear Doctor Letters for Recalls of Implantable Cardioverter Defibrillators (ICDs)," dated July 19 and posted on FDA's Web site July 30. Getting safety information out to doctors as soon as possible "helps them to be better equipped to address patients' concerns and mitigate undue alarm," the guidance notes. FDA emphasizes that communications with health care professionals should avoid promotional statements and concentrate on the immediate problem and recommended actions. The agency also recommends that safety communications be transmitted to health care professionals through multiple channels at once, including e-mail, fax, express mail and the Internet
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