In vitro diagnostics (IVDs), tests conducted on samples taken from the human body, have been indispensable tools in combatting COVID-19. The industry is expected to grow significantly post-COVID-19, due in part to increased use of pandemic-necessitated innovations, such as remote collection and digital pathology. Currently, FDA’s necessary focus on COVID-19 has caused delays in review of IVDs not central to the pandemic response. This webinar will examine the essential role IVDs have played in addressing COVID-19, related compliance issues and enforcement trends, and how the virus-related shutdowns have led to the potential for exciting advancements in the ways IVDs are used. Speakers will also discuss strategies for working with FDA to facilitate review of diagnostics not related to COVID-19 response.

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Toby Lowe, Associate Director, Office of In Vitro Diagnostics and Radiological Health, CDRH, FDA
Brad Spring, Vice President, Regulatory Affairs, Strategic Planning and Policy & US Regulatory Intelligence, BD
Randy J. Prebula, Partner, Hogan Lovells US LLP
Moderated by Allyson B. Mullen, Director, Hyman, Phelps & McNamara, PC and Co-Editor of Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment

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