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Medical Devices Corporate Counsel Food and Drug Administration (FDA)

White & Case LLP

DOJ Secures First of Its Kind Cybersecurity False Claims Act Settlement

White & Case LLP on

On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more

Falcon Rappaport & Berkman LLP

Cannabis Rescheduling – A Look Towards the Future of the Industry

The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more

McDermott Will & Schulte

[Event] Life Sciences Boot Camp For In-House Counsel 2023 - April 4th, South San Francisco, CA

McDermott is pleased to bring our Life Sciences Boot Camp for In-House Counsel back to the Bay Area! Amid turbulent economic forces, life sciences companies continue to grapple with increasingly complex legal and business...more

Hogan Lovells

Five highlights from FDA’s new AI device regulation Action Plan

Hogan Lovells on

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based...more

Kelley Drye & Warren LLP

FTC Settles With Pain Relief Marketer For $4 Million

The FTC announced a settlement with NeuroMetrix, Inc., and its CEO, Shai Gozani, relative to allegations that the marketers made deceptive pain relief claims on a medical device called Quell....more

Seyfarth Shaw LLP

New Federal Contract Reporting Requirements Aimed at Protecting Supply Chains Through Detection of Counterfeit Parts

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Federal contractors already subject to a myriad of reporting requirements should be prepared for yet another. Effective December 23, 2019, a new Federal Acquisition Regulation (“FAR”) provision entitled “Reporting of...more

American Conference Institute (ACI)

[Event] Drug and Medical Device Litigation – the Must-Attend Event for the Life Sciences Products Liability Community - December...

Actionable Strategies for Drug and Medical Device Products Liability Litigators and In-house Counsel - ACI’s Drug and Medical Device Litigation conference is the only event which brings together an exceptional in-house...more

Dorsey & Whitney LLP

POM Wonderful Returns – Lanham Act False Advertising Claim Against Home Pregnancy Tests Not Precluded by FDCA

Dorsey & Whitney LLP on

On September 9, 2016, the Court of Appeals for the Second Circuit issued an interesting decision in a false advertising case involving a dispute between competitors in the home pregnancy testing market. Church & Dwight Co. v....more

Fish & Richardson

Short-Sellers Partnering with Hackers: Exploiting Cybersecurity Fears for Short-Term Profit

Fish & Richardson on

A research report released last week on the supposed cyber vulnerabilities of St. Jude Medical’s devices not only jeopardizes a pending $25 billion acquisition of the company by Abbott Laboratories, it opens a worrisome new...more

Arnall Golden Gregory LLP

Federal Jury Convicts Two Former Acclarent, Inc. Executives on Misdemeanor Charges Related to Off-Label Marketing of Medical...

On July 21, 2016, two former executives of Acclarent, Inc., a medical device company owned by Johnson & Johnson, Inc., were found guilty of ten misdemeanor violations of the Food, Drug and Cosmetic Act (FDCA), following a...more

McDermott Will & Schulte

When Customer Supply Contracts Lead to Trouble: Exclusive Dealing Provisions Result in FTC Monopolization Action against Invibio

The Federal Trade Commission (FTC) continues to aggressively enforce the antitrust laws. On April 27, 2016, the FTC took action against Victrex, plc and its wholly owned subsidiaries, Invibio, Inc. and Invibio Limited...more

Skadden, Arps, Slate, Meagher & Flom LLP

"The Future of Government Regulation, Enforcement of Off-Label Promotion"

Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more

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