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Parker Poe Adams & Bernstein LLP

Is FDA's Civil Money Penalty Authority Dead, and If So, What Does It Mean for Life Sciences Companies?

Does the recent decision in a federal district court in Texas, finding that the U.S. Food and Drug Administration’s tobacco civil money penalty authority is unconstitutional, mean the end of the federal agency bringing...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Blank Rome LLP

[Webinar] 180 Days of the Trump Administration—Quick Hits on Executive Orders, Actions, and Policies - July 17th - August 13th,...

Blank Rome LLP on

Blank Rome presents a new summer webinar series where our interdisciplinary team will unpack the most pressing legal, regulatory, and policy developments from the Trump Administration’s first 180 days. Each session offers...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Cozen O'Connor

FDA Bans Red Dye No. 3 in Food and Ingested Drugs: What Manufacturers Should Know

Cozen O'Connor on

On January 16, 2025, the Food and Drug Administration (FDA) issued an order banning FD&C Red No.3 in food and ingested drugs.1 Food and ingested drug manufacturers who use Red No. 3 have until January 15, 2027, or January 18,...more

Morrison & Foerster LLP

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

Jones Day

DOJ Obtains First Divestitures in a Criminal Antitrust Case

Jones Day on

The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more

Epstein Becker & Green

Beyond HIPAA: FTC’s Data Protection Authority Results in Settlement with Genetic Testing Company

Epstein Becker & Green on

A recent enforcement action by the Federal Trade Commission (“FTC”) against 1Health.io—which sells “DNA Health Test Kits” to consumers for health and ancestry insights—serves as a reminder that the FTC is increasingly...more

Goodwin

SEC Brings Suit Against Owner of BitTorrent, Inc., and Settles Claims With Celebrity Endorsers of Certain Crypto Tokens

Goodwin on

On March 22, 2023, the US Securities and Exchange Commission (SEC) filed a complaint in US District Court for the Southern District of New York against Justin Sun, the owner of BitTorrent, Inc., a file-sharing platform; three...more

Foley Hoag LLP

CFIUS Year in Review

Foley Hoag LLP on

CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - December 2022

Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more

The Volkov Law Group

False Claims Act Round-Up — DOJ Continues Aggressive Prosecution of Healthcare Fraud

The Volkov Law Group on

The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases.  The Justice Department is executing on that promise and doing so with great success.  Week after week, we read about...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Robins Kaplan LLP

Financial Daily Dose 1.14.2020 | Top Story: Amazon Hit with Antitrust Case by India’s Government

Robins Kaplan LLP on

BlackRock Inc. will sell out of all companies “that get more than 25% of sales from thermal coal.” This threshold, however, won’t affect larger, diversified miners—which includes some of the biggest coal shippers....more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Skadden, Arps, Slate, Meagher & Flom LLP

Enforcement and Litigation Strategies: Skadden’s Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar

On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Seventh Annual Pharmaceutical and Medical Device Seminar

Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more

Skadden, Arps, Slate, Meagher & Flom LLP

Key Takeaways: Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies

On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more

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