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Department of Justice (DOJ) Supreme Court of the United States Food and Drug Administration (FDA)

Mintz - Intellectual Property Viewpoints

Regulation, Enforcement, and Associated Challenges: Part II

Given the continued challenges in policing the burgeoning ENDS marketplace, as previously discussed in Part I of this article, in mid-2024 FDA and DOJ announced the establishment of a federal multi-agency task force to combat...more

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

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For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Akin Gump Strauss Hauer & Feld LLP

The Top 10 Takeaways for Businesses from the Supreme Court’s Three Big Administrative Law Decisions in 2024

Now that the dust has settled following the Supreme Court’s overhaul of administrative law through three late-term decisions, Akin litigators and policy advisors offer the most significant takeaways for businesses and...more

Sheppard Mullin Richter & Hampton LLP

Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended...more

Proskauer - Employee Benefits & Executive...

Understanding Recent Litigation on Medication Abortion: A Guide for Health Plan Sponsors

Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Snell & Wilmer

Supreme Court Clarifies That Medical Providers Cannot Be Convicted Of Illegal Drug Distribution If Prosecutors Do Not Prove the...

Snell & Wilmer on

In Justice Breyer’s final opinion from the bench in a 9-0 decision, the United States Supreme Court clarified that for a physician to be criminally convicted of distributing a controlled substance, the Department of Justice...more

ArentFox Schiff

Investigations Newsletters: US Supreme Court Requests Solicitor General's Views in FCA Rule 9(b) Context

ArentFox Schiff on

US Supreme Court Requests Solicitor General’s Views in FCA Rule 9(b) Context - On May 16, 2022, the US Supreme Court requested a brief from the US Solicitor General on the level particularly required by Federal Rule of...more

ArentFox Schiff

Managing Medical Marijuana at Workplace Amid Evolving State and Local Law

ArentFox Schiff on

Since California first legalized medical marijuana in 1996, approximately thirty-two other states and the District of Columbia have followed its lead and approved marijuana use for medical purposes. Introduction [1] - ...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

Hogan Lovells on

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Mintz - ML Strategies

Health Care Update - November 2015

Mintz - ML Strategies on

Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more

Saul Ewing LLP

False claims by any other name: Medtronic and Omnicare cases illustrate the interplay between the False Claims Act and other...

Saul Ewing LLP on

- Government allegations of Medtronic’s alleged incentives to physicians for prescribing its medical devices lead company, while denying wrongdoing, to settle False Claims Act suit predicated on Anti-Kickback Statute. ...more

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