Capital Conversations: COVID-19 and FDA; Medical, Legal, and Regulatory Perspectives

During the COVID-19 pandemic, the United States Food and Drug Administration (FDA) has sought to exercise regulatory flexibilities where possible to expedite the development of timely medical products and ensure the safety of consumers. As the pandemic has evolved and new scientific evidence has emerged, the FDA has needed to adapt its policies and develop new programs to support the public health response. In this teleforum, senior agency officials will share their perspectives on the key medical, legal, and regulatory considerations during the pandemic. Examples of discussion topics will include (1) the application of emergency use authorizations to expedite the development of COVID-19 tests, (2) regulatory lessons from the Coronavirus Treatment Acceleration Program, and (3) legal actions to protect consumers from fraudulent medical products during the pandemic as part of the agency’s Operation Quack Hack.

Featuring:
-- Stacy Amin, Chief Counsel, U.S. Food and Drug Administration; Deputy General Counsel, Department of Health and Human Services
-- Anand Shah, MD, Deputy Commissioner for Medical and Scientific Affairs, U.S. Food and Drug Administration
-- Moderator: Stephen J. Cox, 39th United States Attorney for the Eastern District of Texas