Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA CLE
Why Attend Agenda Location & CLE Continuing Legal Education
Fundamentals of Digital Health Regulation: Successfully Navigating Your Product Through FDA Agenda
Why Attend Agenda Location & CLE Subject to change All times are in Eastern Time 2022 Curriculum Advisor: Shelby Buettner, Assistant General Counsel and Compliance Officer, Becton Dickinson (BD) Wednesday, November 30 11:00–11:05 AM Welcome and Course Overview Khara L. Minter, Assistant Director, Training Programs, FDLI [...]
Summer Learning Series: Enforcement Authorities in Inspection and Compliance: What You Need to Know
The Summer Learning Series brings the top thinkers and leaders of our industry to speak on a broad array of topics essential to the food and drug law professional, covering matters that perhaps we all wish we knew a bit more about as we work and converse with clients, colleagues, and the FDA. This [...]
Publications Coordinator
PUBLICATIONS COORDINATOR DESCRIPTION The Food and Drug Law Institute (FDLI) is a nonprofit membership organization that offers education, training, publications, and professional engagement opportunities in the field of food and drug law. As a neutral convener, FDLI provides a venue for stakeholders to inform innovative public policy, law, and regulation. FDLI’s scope covers all [...]
Top Food and Drug Cases
Top Food and Drug Cases, 2021, & Cases to Watch, 2022 FDLI’s Top Food and Drug Cases is the companion volume to the popular panel at our Annual Conference. View the full version here. Become A Member Introduction August T. Horvath, Foley Hoag LLP and Editor, Top Food and [...]
Judge Rotenberg Educational Center v. U.S. Food and Drug Administration
Judge Rotenberg Educational Center v. U.S. Food and Drug Administration VÉRONIQUE LI, FARAZ SIDDIQUI & JEFF GIBBS* Why It Made the List The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for patients with [...]
Center for Food Safety v. Becerra
Center for Food Safety v. Becerra T. DANIEL LOGAN & JACQUELINE J. CHAN* Why It Made the List Occasionally, important cases are those that maintain, rather than alter, the status quo. This case1 is included in this volume because it does just that: it maintains the voluntary notification procedure, created by the Food and [...]
Federal Trade Commission v. Martin Shkreli
Federal Trade Commission v. Martin Shkreli BRYANT GODFREY & TINA PAPAGIANNOPOULOS* Why It Made the List The Federal Trade Commission (FTC) has been investigating and enforcing against potential anticompetitive conduct in the pharmaceutical industry for decades. The complexity of the regulatory framework under the Federal Food, Drug, and Cosmetic Act (FDCA), however, makes antitrust [...]
AMG Capital Management, LLC v. Federal Trade Commission: No Money for You! Supreme Court Holds FTC Cannot Obtain Equitable Monetary Relief Without First Going Through Its Administrative Adjudication Process
AMG Capital Management, LLC v. Federal Trade Commission: No Money for You! Supreme Court Holds FTC Cannot Obtain Equitable Monetary Relief Without First Going Through Its Administrative Adjudication Process LYNN C. TYLER* In AMG Capital Mgmt., LLC v. FTC, 141 S. Ct. 1341 (2021) (“AMG Capital”), the Supreme Court held that the Federal Trade [...]
Salinero v. Johnson & Johnson et al.
Salinero v. Johnson & Johnson et al. GINGER PIGOTT & MICHAEL GOODMAN* Why It Made the List The term “learned intermediary” originated in the Eighth Circuit decision of Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966)1 and today is applied in most U.S. jurisdictions to define the warning obligations for prescription [...]
