Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed

PROJECT SUMMARY The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration's (FDA or the Agency) is seeking proposals for collaborative research and convening activities 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 postmarket surveillance. Building on over fifteen years of experience working collaboratively with the FDA on such topics, the Duke-Robert J. Margolis, MD, Institute for Health Policy at Duke University (Duke-Margolis) proposes to continue engaging with teams at

FDA/CDER to jointly tackle a range of priority public health issues, leveraging our access to a wide variety of experts within the Duke ecosystem and our strong relationships with a diverse range of external stakeholders to advance aims in the following areas: Specific Aim 1: Execute collaborative research projects with FDA to support the Agency and its stakeholders by

exploring and addressing a range of critical and pressing public health topics related to FDA's oversight of medical products, policy, and surveillance methods and systems. Our approach incorporates a wide array of stakeholder perspectives, including those from emerging areas and/or new to engaging with FDA, to explore key

topic areas through impactful convenings, facilitate the identification of practical and actionable solutions, support the Agency in its essential public health activities, and bring benefits to patients. Specific Aim 2: Synthesize and distill the research, stakeholder input, and event discussions in Aim 1 to identify

concrete, actionable next steps and recommendations for all stakeholder groups, including FDA, to pursue. In achieving this aim, we will develop a range of audience-tailored deliverables that lay out avenues for progress. Specific Aim 3: Disseminate the findings and recommendations developed under Aim 2 to key stakeholders and

the public in a transparent manner, promoting trust and driving policy advancement in priority areas. Convening and research materials will be posted publicly on Duke-Margolis event webpages as appropriate and findings shared through those and other venues selected to reach broad audiences and drive progress.