Overview
Panelists will provide an overview of the Omnibus bill and discuss 1) How the Food and Drug Omnibus Reform Act (FDORA), makes significant changes to several aspects of medical device and drug premarket review, as well as drug marketing exclusivity; 2) The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which expanded FDA’s authority to regulate cosmetics since the FD&C Act of 1938; 3) Changes to medical device law in cybersecurity, data transparency, and real-world evidence, among others; and 4) Establishment of an Office of Critical Foods within CFSAN.
Speakers
Samantha Hong, Associate, Kleinfeld, Kaplan & Becker LLP
George A. O’ Brien, Partner, Mayer Brown LLP
Moderated by Laura Pence, Director, Leavitt Partners, LLC
SAMANTHA HONG is an associate at Kleinfeld, Kaplan & Becker where she advises clients in the food, drug, cosmetic, and dietary supplement industries on wide-ranging legal and regulatory matters related to the Food and Drug Administration (FDA) and other federal and state agencies. Samantha previously served as an Associate Chief Counsel in the Office of the Chief Counsel at FDA where she handled enforcement matters across all product areas and litigated challenges to agency actions on issues ranging from drug exclusivity to emergency use authorizations. Prior to her government tenure, Samantha worked as a patent litigator at two international law firms.
GEORGE O’BRIEN is a partner in the FDA-Pharmaceutical and Biotechnology practice group at Hogan Lovells US LLP, based out of the Washington DC office. George works with innovative pharmaceutical and biotech companies on lifecycle management issues, including patent listing and exclusivity matters, as well as orphan drug and pediatric issues.March 2, 2023
12:00–1:00 PM ET
This program is limited to FDLI members who are a part of the New to FDA Law and Regulation Group and student members. Registration expires on March 1, 2023.
APPLY FOR THE GROUP AND REGISTER FOR THE EVENT
New to FDA Law and Regulation Group
New to FDA Law and Regulation Group offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
