Manufacturers, Life Sciences, Department of Justice (DOJ)

FDA Unauthorized ENDS Enforcement: 2024 Mid-Year Roundup

Troutman Pepper on 7/5/2024

In the first half of 2024, the U.S. Food and Drug Administration (FDA) has continued to ramp up efforts to limit sales of unauthorized electronic nicotine delivery systems (ENDS). We previously reported on FDA’s heightened...more

FDA Continues ENDS Enforcement with New Injunction and Civil Money Penalty Proceedings

Troutman Pepper on 12/6/2023

The Food and Drug Administration (FDA) has recently filed new injunction and civil money penalty proceedings against unauthorized, flavored e-liquids and electronic nicotine delivery systems (ENDS) manufacturers and...more

eDiscovery and Life Sciences Industry - Challenges and Solutions

Ankura on 5/5/2023

The life science industry is a significant contributor to the global market, with companies developing and manufacturing a wide range of medical products and devices. However, due to the complex and highly regulated processes...more

FDA’s Final Rule on Intended Use: ‘Getting Right Back to Where We Started From’

Skadden, Arps, Slate, Meagher & Flom LLP on 8/18/2021

On August 2, 2021, the U.S. Food and Drug Administration (FDA) issued its final rule amending the intended use regulations codified at 21 CFR 801.4 and 21 CFR 201.128, marking the end of an effort FDA began in 2015. While the...more

Novel DOJ Settlement For Sunshine Act Violations

Goodwin on 10/30/2020

On October 29, 2020, the U.S. Department of Justice (“DOJ”) announced a unique False Claims Act (“FCA”) settlement with medical device manufacturer Medtronic USA Inc. (“Medtronic”) for $9.2 million to resolve allegations...more

The Life Sciences Report - Spring 2015

Wilson Sonsini Goodrich & Rosati on 6/24/2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more