Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act (U19)

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PROJECT SUMMARY 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 to advance and promote regulatory science and more efficient development of safe and effective drugs for patients in need. Building on almost 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 policy, scientific, and operational challenges as prioritized by FDA, the pharmaceutical industry, and Congress in 2018’s Prescription Drug User Fee Act VI (PDUFA VI) and 2017’s 21st Century Cures Act (Cures). Through this new cooperative agreement, and in keeping with goals in PDUFA VI and Cures to expedite development through trusted science, Duke-Margolis proposes to expand on our existing collaboration with FDA by partnering with CDER, C-Path, 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 in addressing complex drug development and regulatory review challenges as outlined in PDUFA VI and Cures. 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.