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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Minnesota lawmakers lobby Hamburg on 510(k) reform: Sen. Amy Klobuchar, D-Minn., and Rep. Erik Paulsen, R-Minn., sent a letter to FDA Commissioner Margaret Hamburg May 26 expressing concerns over potential changes to the 510(k) device clearance process and urging the commissioner to avoid modifications that would add "new and unnecessary regulations, resulting in an even longer and more complicated approval process." FDA is reviewing its 510(k) program internally, while the Institute of Medicine undertakes a concurrent 510(k) program review. CDRH is still compiling an internal report for Center Director Jeffrey Shuren. He could not predict when a copy of the report would be released publicly

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Regulatory News In Brief

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urges stricter requirements for advisory committee members with financial conflicts in June 21 comments on FDA's latest draft guidance regarding advisory committee member financial conflicts of interest and waivers.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 The March 2010 draft guidance is FDA's third attempt to carve out policies for financial conflicts of interest, following a draft guidance in 2002 and final guidance in 2008 (1"The Gray Sheet" April 26, 2010).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

Regulatory News In Brief

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urges stricter requirements for advisory committee members with financial conflicts in June 21 comments on FDA's latest draft guidance regarding advisory committee member financial conflicts of interest and waivers.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

Regulatory News In Brief

Upcoming IOM 510(k) meetings: The Institute of Medicine task force commissioned to review FDA's 510(k) pre-market submissions program will hold its next two public meetings on June 14-15 and July 28 in Washington, D.C., the agency announced. The workshops will help IOM gather information to inform recommendations for potential reforms of the 510(k) program. IOM held its first 510(k) meeting March 1(1"The Gray Sheet" March 8, 2010)

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