This year marks the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). The user fee program was created to authorize the Food and Drug Administration (FDA) to collect user fees from biopharmaceutical companies to supplement its funding and review and approve innovative products faster and more efficiently. Thanks to PDUFA, the United States is the world leader in the development of biomedical products. Please join us for a PDUFA 101 congressional briefing to learn more about why the program was created, how it works and provides resources to the FDA, and how it has enabled the development of revolutionizing treatments and benefitted patients around the world. Participants will also learn about the reauthorization cycles, upcoming agreement, and other user fee programs.
– Danielle Friend, Ph.D., Director, America Policy, Janssen Research & Development, Global Regulatory Policy & Intelligence
– Khushboo Sharma, Senior Vice President of Science and Regulatory Affairs, Biotechnology Innovation Organization
*Attendees will receive webinar login credentials upon registering
This event will be held in strict accordance with House and Senate Ethics rules