Cooperative Agreement to Support Regulatory Research Related to the 2022 Prescription Drug User Fee Act and Biosimilar User Fee Act (U19)

项目总结

PROJECT Summary The Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) is seeking proposals for collaborative research and convening activities to advance and promote regulatory science in several key areas prioritized by the FDA, the pharmaceutical industry, and Congress in 2022’s Prescription Drug User Fee Act VII (PDUFA VII) and Biosimilar User Fee Act (BsUFA III). Building on more than fourteen years of collaborative working experience with the FDA on priority topics, the Duke-Robert J. Margolis, MD, Center for Health Policy (Duke-Margolis) proposes to continue collaborating with the FDA to tackle the range of policy, scientific, and operational challenges identified in PDUFA VII and BsUFA III. Duke-Margolis will build on its past experience to work collaboratively with FDA to identify priority topics for development and delivery of up to nine collaborative research and convening activities that include the annual completion of up to four large public conferences, two private expert workshops, and three other convening activities (e.g., think tanks, webinars) as needed and achievable under the annual budget. Depending on the intended convening purpose or need, convenings may be virtual, hybrid, or in-person. Through this new cooperative agreement, and in keeping with goals in PDUFA VII and BsUFA III to expedite development through trusted science, Duke-Margolis proposes to expand on our existing infrastructure, extensive stakeholder relationships, convening experience and expertise, and positive track record of collaboration with numerous FDA Centers and Offices to achieve the following aims: Specific Aim 1: Implement a multidisciplinary, multi-stakeholder, and collaborative research and convening program to support FDA and its stakeholders in addressing complex drug development and regulatory review challenges as outlined in PDUFA VII and BsUFA III. Specific Aim 2: Synthesize and distill the core background research, stakeholder input, and workshop or meeting discussions pursued in Aim 1 to promote and establish concrete, actionable next steps and recommendations for all stakeholder groups. 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. Duke-Margolis is uniquely suited to collaborate with the FDA to advance research in the key areas identified in PDUFA VII and BsUFA III. We seek to build on our senior team’s fourteen years of experience working collaboratively with the FDA through other such cooperative agreements to engage stakeholders on high- priority questions of interest, develop recommendations and models for making progress, and advance regulatory science and more efficient development of safe and effective drugs for patients in need.