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Innovation, Regulation, and Intellectual Property in the Life Sciences, Session 2: FDA Innovation
December 3, 2020 @ 12:00 pm - 1:00 pm
This session will examine how the FDA itself is innovating, considering both pandemic-related issues as well as longer term trends in the life sciences that have prompted innovation at the FDA. Topics will include the latest agency practices around Emergency Use Authorizations, fast track trials, post-approval tracking, and developments with respect to Hatch-Waxman and the intersection of FDA and PTO authorities.
Dr. Michelle McMurry-Heath, CEO of BIO
Charles Andres, Wilson Sonsini
Sally Allain, Johnson and Johnson Innovation