The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration?s (FDA) is seeking proposals for collaborative research and convening activities advance regulatory science, policy, and procedures to address a range of critical public health topics, including drug development, drug approval, bioresearch monitoring, human subject protection, and post market surveillance. Building on over ten years of collaborative experience working with the FDA on such topics, the Duke-Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) proposes to continue collaborating with CDER to tackle a range of priority public health issues. Through this new cooperative agreement Duke-Margolis proposes to expand on our existing collaboration with FDA by partnering with CDER and experts within the Duke ecosystem to advance the following aims:
Specific Aim 1 : Implement a multidisciplinary and collaborative research and convening capacity to support FDA and its stakeholders to explore and address a range of critical public health topics related to FDA?s oversight of medical products, policy, and surveillance methods and systems. Our approach will incorporate a wide array of stakeholder perspectives, facilitate the identification of practical and actionable solutions, and support the public health mission of FDA.
Specific Aim 2 : Synthesize and distill the core research, stakeholder input, and workshop or meeting discussions pursued in Aim 1 to establish concrete, actionable next steps and recommendations for all stakeholder groups, not just FDA, to pursue.
Specific Aim 3 : Disseminate the findings and recommendations developed under Aim 2 to the public in a transparent and timely method, with an eye toward continually engaging stakeholders to further refine and implement key concepts and recommendations where feasible and appropriate.
The U.S. Food and Drug Administration (FDA), through its Office of Medical Policy (OMP), has sought to advance regulatory science, policy, and procedures to address a range of critical public health topics, including drug development, drug approval, bioresearch monitoring, human subject protection, and post market surveillance. The advancement of these critical public health needs requires collaboration with a broad range of stakeholders through convening activities that help advance scientific understanding of these topics, focus on key policy and procedural needs of evolving initiatives, and support or fulfill statutory commitments or requirements. The Robert J. Margolis, MD, Center for Health Policy at Duke University proposes to support the FDA in advancing its medical policy development through rigorous collaborative research and convening activities, building on Duke- Margolis and FDA?s decade-long track record of developing and delivering trusted, high-impact stakeholder engagement and research deliverables on priority regulatory and public health issues.
