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The FDA uses advisory committees and panels to obtain independent expert advice on scientific, technical, and policy matters. Advisory Committee Meetings (ACMs) may be convened if the agency has significant questions or concerns about clinical data submitted for review. Statisticians from both FDA and industry can play a key role in providing insight into the data under review in an ACM. This requires extensive preparation and planning which extends beyond the data provided in the submission package. In this article, we review the contributions of industry Statisticians in the planning, preparation and responses for ACMs.

Experience with Advisory Committee Meeting Preparation and Execution