Convener of Discussions on Medical Policy Issues Impacting Drug Development

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The Office of Medical Policy (OMP) provides CDER oversight and leadership in the development of medical policy, procedures, and policy initiatives pertaining to drug development, drug approval, bioresearch monitoring, human subject protection and post market surveillance processes. When developing and implementing policy, a key step is often to create a broad public forum with a variety of stakeholders to identify key issues that will need to be addressed before, during, and after implementation of any initiative. These discussions can help focus many of the policy and procedural needs of an evolving initiative. The goal of such meetings is not to obtain advice relating to regulatory actions or to make decisions. Nor is the goal to reach a consensus among the participants on any of the issues discussed. Rather, it is to hear the opinions of experts in the field and other individual stakeholders. In addition, it is important to maintain transparency. The goal of these meetings is to be as inclusive as possible, while still limiting participation to a number that supports the meetings goals and objectives. However, it is important to ensure that information from these meetings and working groups must be described, managed, and made available to the public using a transparent and open approach.

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