The FDA has acknowledged that the COVID-19 epidemic could cause critical medical product disruptions and shortages, particularly with imports from China. FDA is actively working with companies to identify potential shortages and mitigate any impacts as early as possible. FDA has also recently approved several Emergency Use Authorizations (EUAs) for medical products used to diagnose or prevent transmission of COVID-19. What is FDA’s role in responding to public health emergencies such as COVID-19? What is FDA’s process for issuing drug, device, or biologics EUAs? What other tools does the agency have to decrease the impact of supply chain disruptions, product shortages, and disease outbreaks, and what are the legal limits to FDA’s authority? How does FDA work with other agencies and entities such as the Centers for Disease Control and Prevention and World Health Organization?
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John Johnson III, Counsel, Shook, Hardy & Bacon LLP
Howard R. Sklamberg, Partner, Akin Gump Strauss Hauer & Feld LLP
Moderated by Jeffrey K. Shapiro, Partner, Hyman, Phelps & McNamara, PC
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