Regulatory News In Brief

FDA will begin publicly disclosing the name of the company or institution associated with an advisory committee member’s financial conflict of interest, according to a final guidance released March 9. The document, “Public Availability Of Advisory Committee Members’ Financial Interest Information and Waivers,” includes minor revisions to the April 2010 draft to improve clarity, and replaces an August 2008 guidance, FDA says. (See Also see "FDA Works To Fill Panel Vacancies While Tightening Conflict Rules" - Medtech Insight, 26 April, 2010..) FDA is required to vet all potential advisory committee members for conflicts of interest and disclose on its website “the type, nature and magnitude of any disqualifying financial interest” when considering giving a waiver to a potential advisory committee member. FDA also will indicate the magnitude of a financial interest by dollar range, such as $0-$5,000, on its website.

FDA issued its scientific integrity policy in a staff manual guide that went into effect on Feb. 3. The 11 key integrity principles include shielding the agency's science...