FDA advisory committee changes
This article was originally published in The Tan Sheet
Executive Summary
FDA releases a 1draft guidance on changes to advisory committee processes, according to a notice slated for publication in the Nov. 19 Federal Register. Among changes, advisory committee members would vote simultaneously rather than sequentially on issues before the panel to avoid influencing one another's votes, the agency says. Although FDA does not mandate any particular voting method, it suggests voting by show of hands, a simultaneous show of "yes" or "no" cards or written balloting. Changes are part of ongoing reforms to the agency's advisory committee policies based on recommendations from the Institute of Medicine and pressure from Congress. In March, FDA issued a draft guidance limiting the potentially conflicting financial interests of members (2"The Tan Sheet" March 26, 2007, p. 7)...