People In Brief
This article was originally published in The Gray Sheet
Executive Summary
CDRH needs new ombudsman: Les Weinstein served his last day as ombudsman for FDA's device center April 9 and now moves to the same post within FDA's new Center for Tobacco Products. Weinstein was appointed as CDRH's first ombudsman in 2000 to handle complaints from outside the agency and disputes between the center and companies. CDRH has yet to name a replacement (1"The Gray Sheet" March 20, 2000). Weinstein released his final annual report for the device center April 7
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Correction
"The Gray Sheet" incorrectly reported in the June 28, 2010, issue that David Buckles, who has become acting ombudsman in the Center for Devices and Radiological Health, will occupy the spot vacated by Casper Uldriks. Buckles will in fact be filling the spot vacated by longtime ombudsman Les Weinstein (1"The Gray Sheet" April 12, 2010). Uldriks' former position as associate director for clinical research & government affairs within the Office of the Center Director is still vacant
Correction
"The Gray Sheet" incorrectly reported in the June 28, 2010, issue that David Buckles, who has become acting ombudsman in the Center for Devices and Radiological Health, will occupy the spot vacated by Casper Uldriks. Buckles will in fact be filling the spot vacated by longtime ombudsman Les Weinstein (1"The Gray Sheet" April 12, 2010). Uldriks' former position as associate director for clinical research & government affairs within the Office of the Center Director is still vacant
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urges stricter requirements for advisory committee members with financial conflicts in June 21 comments on FDA's latest draft guidance regarding advisory committee member financial conflicts of interest and waivers.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 The March 2010 draft guidance is FDA's third attempt to carve out policies for financial conflicts of interest, following a draft guidance in 2002 and final guidance in 2008 (1"The Gray Sheet" April 26, 2010).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