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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 April 2, 2025

Supreme Court Upholds FDA’s Denial Of Marketing Authorization For Flavored E-Cigarettes

The Supreme Court held unanimously that the Food and Drug Administration did not unlawfully change position in denying marketing authorization for flavored e-cigarettes.

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.

Webcasts March 11, 2025

Webcast: Consumer Protection and Enforcement – Trends and Expectations

Featuring experienced practitioners and former officials from DOJ’s Consumer Protection Branch and the FTC, this webcast discusses trends in the enforcement of consumer health, safety, fraud, and privacy laws.

Webcasts February 25, 2025

Webcast: Year-End FCA Updates for Life Sciences Companies

Looking back at 2024 and forward to the new year, False Claims Act (FCA) enforcement in the life sciences industry …

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 23, 2025

False Claims Act 2024 Year-End Update

In this update, we cover recent developments in FCA jurisprudence, summarize significant enforcement activity, and analyze the most notable legislative, policy, and caselaw developments from the second half of calendar year 2024, picking up where our last update left off.

Client Alert January 23, 2025

DEA Proposes New Rule to Restrict Telemedicine Prescriptions

Gibson Dunn has deep expertise related to controlled substances laws, with partners across practice groups having served in leading enforcement and regulatory government roles. We are available to help clients understand the new proposed rule and consider how to respond to it.