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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Conflict of interest comments: The American Association for Justice urges stricter requirements for advisory committee members with financial conflicts in June 21 comments on FDA's latest draft guidance regarding advisory committee member financial conflicts of interest and waivers. AAJ, formerly the Association of Trial Lawyers of America, believes conflicted persons should not be allowed to serve even as non-voting members, because "a non-voting member can still wield enough influence ... to upset the vote," the group writes. The Breast Cancer Action group, meanwhile, urges FDA to create guidelines requiring agency staff to contact a specific number of experts before a waiver can be deemed necessary. The March 2010 draft guidance is FDA's third attempt to carve out policies for financial conflicts of interest, following a draft guidance in 2002 and final guidance in 2008 (1"The Gray Sheet" April 26, 2010). The recent draft amends the prior versions to require public disclosure of the source of financial conflicts, which several commenters applauded

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