In an effort to bring this very informative session to those who can not attend the DIA 42nd Annual Meeting we would like to offer you this interactive audio conference which will be broadcasted LIVE from the Annual Meeting. Participants will be able to submit questions from the comfort of their office to senior leadership from the US FDA Center for Drug Evaluation and Research through an anonymous email. Topics discussed during this live session and audio conference will depend entirely on the content of these participants’ questions.