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    Preparing for an FDA Advisory Committee Approval Meeting

    This article discusses the nuances of FDA Advisory Committee approval meetings and provides an interpretive overview of what regulatory professionals need to know to prepare for a meeting. Introduction The US Food and Drug Administration (FDA) define an Advisory Committee simply as a group of external experts convened to offer advice to the agency. However, in realty, the practice is more complicated. In other places on its website, FDA states Advisory Committees can ...