Food, Drug & Cosmetic Law Section 2024 Spring Meeting

What will the healthcare/life science legal landscape look like in 2024?

With the rise of personalized medicine, digital therapeutics and AI, we can expect new laws and regulations governing these healthcare innovations. The FDA and the FTC have expanded their oversight of cosmetics and health claims, respectively. We await the Supreme Court opinion on who has standing to challenge FDA drug approvals, and the possible avalanche of challenges if the appellate court definition is affirmed. 

Hence the need to examine how these changes will impact the healthcare and life science legal community. 

This year’s Spring Meeting focuses on the following:

-The Modernization of Cosmetic Regulations Act of 2022 and its impact on the industry.

-The implementation of FTCs healthcare product compliance guidelines.

-The next regulatory frontier for telemedicine post Covid-19.

-Use of AI in drug research and predictive personalized patient care, and the legal issues around these uses.

-Will the mifepristone decision redefine standing to challenge FDA drug approvals?

Speakers

Brian Malkin, Esq., Associate General Counsel, Regulatory Law, Teva Pharmaceutic

Mati Gill, CEO, AION Labs, Tel Aviv-Yafo, Israel

Eran Harary, MD, SVP, Global Clinical Development, Head, Innovative Medicines R&D, Teva Pharmaceutical Sciences

Thomas A. Cohn, Esq., Senior Director and Counsel, Marketing and Product, Hello Fresh

Julie Dohm, Esq., Covington & Burling LLP

Huanyu Zhou, Senior Director, Head of AI Science, Teva Pharmaceutical Industries

Stefanie Kraus, JD, MPH, Senior Regulatory Counsel, U.S. Food and Drug Administration CDER, Office of Regulatory Policy

Janet B. Linn, Esq., Tarter, Krinsky & Drogin

Tala Fakhouri, PhD, MPH, Associate Director for Policy Analysis, U.S. Food and Drug Administration CDER, Office of Medical Policy

Ron Lanton III, Esq., Lanton Law, PLLC

Casandra Lanton, Lanton Law, PLLC

Dorothy Charach, Partner, McCarthy Tetrault, Toronto

Kelly Goldberg, Esq., Vice President, Law and Senior Counsel for Biopharmaceutic Regulation, PhRMA

David L. Rosen, BS Pharm., JD., Foley & Lardner LLP, FDA Practice Group Leader, (Former FDA/CDER Senior Official)

Samantha Wasserman, Associate, McCarthy Tetrault, Toronto

Mathew Chun, Patent Agent, Fish & Richardson, JD Candidate, Harvard Law School