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    Post-Marketing Plans: An Often Overlooked Component of FDA Advisory Committee Meeting Discussions

    The article analyzes the proportion of FDA Advisory Committees specifically asked to discuss or vote on issues related to post-approval safety activities. Introduction Preparing effectively for a US Food and Drug Administration (FDA) Advisory Committee meeting requires the sponsor team's anticipation of discussion and voting topics FDA will pose to the advisory panel. Discussion topics and voting questions will influence information the team provides to the panel as w...