Abstract
Since 1992 many changes have occurred in the regulations, guidelines, and processes governing the FDA, the biomedical industry, other stakeholders, and their interactions. Of particular importance, the FDA Amendments Act of 2007 made public advisory committee meetings mandatory for new molecular entities and devices requiring clinical trials, unless the necessity of convening such a meeting has been waived by the FDA commissioner. For effective preparation, product teams must now assume that such a public review will be necessary, even if not initially specified by the FDA's review team. To understand what advisory committee members actually want from sponsors to enable their informed participation, the authors surveyed 101 current or former members of one of the FDA's public biomedical advisory committees within the Center for Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health. Their goal was to understand more fully their preparatory practices and preferences regarding materials provided by the sponsor and the FDA, advisory committee presentations, and Q&A sessions. The findings suggest that sponsors need to be clear, concise, and scientifically credible, and that some advisory committee members need to be more uniformly prepared.