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Policy

FDA Amends Disclosure Rules

November 26, 2007 | A version of this story appeared in Volume 85, Issue 48

FDA is proposing changes to several policies to improve its science advisory committee process. Most significant, the agency recommends changes to its public disclosure policy for potential conflicts of interest for advisory committee members. According to FDA, the draft guidance would make the process more transparent and consistent by requiring all committee members to publicly disclose interests for which a waiver could be granted. New disclosure and waiver material that is easier for the public to understand will help effect this transparency. A study done for FDA by the Eastern Research Group, a consulting firm, noted that it is difficult to assemble highly qualified scientific experts who are free of all conflicts of interest and that experts who received waivers in order to serve on a committee were significantly more qualified than those who did not receive waivers. Other changes recommended by the agency include a requirement for simultaneous voting and immediate announcement of results, as well as new procedures for maintaining decorum and public conduct at committee hearings.

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