Why Attend Agenda CLE Tuesday, June 8 11:00–11:45 AM Bonus Session: A Primer on Regenerative Medicine Science and Recent Breakthroughs Heather C. Hatcher, Regulatory Scientist, Womble Bond Dickinson (US) LLP Collin Stabler, Senior Associate, Exponent, Inc. Moderated by Barbara A. Binzak Blumenfeld, Shareholder, Buchanan Ingersoll & Rooney PC [...]
Why Attend Agenda CLE Continuing Legal Education
Why Attend Agenda Agenda Subject to Change. All Times are Eastern Time. CLE Tuesday, May 18 Amy Comstock Rick, President & CEO, FDLI Stuart M. Pape, Senior Partner, Polsinelli PC and Co-Chair, 2021 FDLI Annual Conference Janet [...]
New, Emerging, and Continually Interesting Issues Discuss emerging issues in transitional biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference Product (RP) exclusivity. Scott M. Lassman , Principal, Lassman Law + Policy SCOTT M. [...]
Update Magazine | Spring 2021
Why Attend Agenda CLE Continuing Legal Education
Why Attend Agenda CLE Subject to Change Wednesday, March 24 11:20 – 11:40 AM Technology and Connection Support Session First virtual conference? Unsure about technology? Join FDLI staff for this informal, open session to make sure your audio and technology are prepared for [...]
Softbound | 230 pages
After the Juice Wars: The Post-POM Wonderful Legal Landscape and its Implications for FDA-Regulated Industries Rachel Simon ABSTRACT Five years have passed since POM Wonderful LLC v. Coca-Cola Co. established that the Federal Food, Drug, and Cosmetic Act (FDCA) does not preclude Lanham Act claims targeting FDA-regulated beverages. Few scholars, however, have evaluated the [...]
Why Attend Agenda CLE Tuesday, December 15 11:30 – 11:45 AM FDLI Welcome and Introductions Amy Comstock Rick, President & CEO, FDLI Sonali P. Gunawardhana, Of Counsel, Shook, Hardy & Bacon LLP and Chair, 2020 Enforcement, Litigation, and Compliance Conference 11:45 AM –12:15 PM Keynote Address Daniel Feith, Deputy [...]
