Intro to COVID-19: Public Readiness and Emergency Preparedness Act (PREP ACT)
This session will delve into the Public Readiness and Emergency Preparedness (PREP) Act, which establishes liability immunity and creates a compensation program for public health emergencies. Cases studies regarding face masks, hand sanitizers, and prescription drug emergency use authorizations are included.
Joshua Oyster, Senior Associate, Ropes & Gray LLP
This session was recorded as part of FDLI’s virtual course, “COVID-19: Introduction to FDA’s Existing Legal Authorities and Emerging Issues” on August 18, 2020.
JOSHUA OYSTER is an associate in the Life Sciences Regulatory and Compliance practice group at Ropes & Gray LLP. His practice focuses on a wide range of regulatory and compliance issues faced by life sciences and health care companies regulated under the Federal Food, Drug, and Cosmetic Act and related laws. Mr. Oyster regularly counsels clients on responding to FDA inspections and enforcement matters, conducts regulatory due diligence on behalf of firms investing in biologics companies, and advises clients on evolving FDA requirements and guidelines, including developments related to biosimilars.Get Access
$99
- +$100 for nonmembers
Legal issues regarding the response to COVID-19 is a rapidly evolving field. It is important to note the program recording date given that FDA guidance may have revised or been updated. For questions, please check the FDA website at: https://www.fda.gov/home
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