New, Emerging, and Continually Interesting Issues

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biologics, FDA protein definition, labeling carve-outs and carve-ins, authorized biosimilars, advertising and promotion draft guidance, purple book reform, and FDA’s umbrella policy for Reference Product (RP) exclusivity.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. [...]

New, Emerging, and Continually Interesting Issues2022-04-04T10:52:02-04:00

2021 Food and Dietary Supplement Safety and Regulation Conference Agenda

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 [...]

2021 Food and Dietary Supplement Safety and Regulation Conference Agenda2021-03-23T15:04:03-04:00

After the Juice Wars: The Post-POM Wonderful Legal Landscape and its Implications for FDA-Regulated Industries

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 [...]

After the Juice Wars: The Post-POM Wonderful Legal Landscape and its Implications for FDA-Regulated Industries2023-02-15T14:11:30-05:00

2020 Enforcement, Litigation, and Compliance Conference Agenda

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 [...]

2020 Enforcement, Litigation, and Compliance Conference Agenda2020-12-15T08:24:28-05:00
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