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

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.