News & Insights
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Client Alert July 30, 2025
FDA and USDA Look to Define “Ultra-Processed Foods”: What You Need to Know
Our lawyers discuss the publishing of a request for information by U.S. Food and Drug Administration and U.S. Department of Agriculture seeking public input on the definition of “ultra-processed foods.”
Client Alert April 4, 2025
FDA’s User Fee Programs at a Crossroads: User Fee Deadlines and Funding at Risk
Gibson Dunn is closely monitoring developments and is prepared to help companies consider and address the implications of potential changes to FDA’s funding structure and authorities, including through regulatory counseling, agency and legislative engagement, and litigation.
Client Alert March 12, 2025
A Storm Brewing: Kennedy Directs FDA to Revamp Pathway for Establishing Safety of Food Ingredients
While the proposal is in its early stages, companies in the food industry should consider efforts to engage in any forthcoming notice-and-comment regulatory process, including by submitting comments on any proposed regulation and participating in related public meetings.
Firm News February 13, 2025
Gibson Dunn Advises J.P. Morgan on Participation as Lead Investor in Series C Financing Round of Olipop
Gibson Dunn advised J.P. Morgan on its participation as lead investor in the Series C financing round of Olipop, a prebiotic beverage company.
Client Alert January 15, 2025
FDA Publishes Proposed Rule on Front-of-Package Labeling – What You Need to Know
Comments on the Front-of-Package Proposed Rule must be submitted to FDA by May 16, 2025.
Client Alert January 9, 2025
“Healthy” Claims, Allergens, Heavy Metals, and More: FDA Acts on Food Safety and Nutrition Labeling Priorities in Biden Administration’s Last Days
Gibson Dunn is prepared to help interested parties consider the implications of these policies and potential responses, including through regulatory counseling, FDA and legislative engagement, and litigation.
Client Alert January 8, 2025
FDA to Require Confirmatory Trials Be “Underway” Prior to Accelerated Approval, Per New Draft Guidance
Life sciences companies interested in pursuing accelerated approval should ensure they have a thorough understanding of the complex regulatory landscape and engage in early discussions with FDA regarding their drug development programs.
Client Alert July 16, 2024
FDA Issues Overdue Guidance on Diversity Action Plans in Drug and Device Clinical Trials – What You Need to Know
On June 26, 2024, FDA released its long-awaited draft guidance on Diversity Action Plans to increase enrollment of underrepresented populations in clinical trials of drugs and devices.