A Transformative Year: A Conversation with the FDA on COVID-19 and Medical Innovation for Older Adults in 2020
The 2020 Roundtable Discussion was held virtually on Tuesday, September 15, 2020.
The Food and Drug Administration (FDA) is having one of its most transformational years to date. The agency is working around the clock to address COVID-19, beginning negotiations for FDA Reauthorization Act (FDARA), releasing final guidance on Patient-Focused Drug Development (PFDD), and working to enhance the diversity of our clinical trial populations.
This panel featured senior officials from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) for a discussion on the agency’s response to the pandemic, the User Fee Agreements, and a discussion on its work to collect more meaningful data from patients and improve the inclusion of underrepresented groups in clinical trials, particularly older adults.
Speakers:
Sue Peschin, MHS
President and CEO
Alliance for Aging Research
Patrizia Cavazzoni, M.D.
Acting Director, Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Brian S. Kersten, Ph.D.
Divisional Vice President, Global Regulatory Services
Abbott Laboratories
Jeff Shuren, M.D., J.D.
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration
source