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Statutory Interpretation Food and Drug Administration (FDA) Healthcare

Gardner Law

Whoop vs. FDA

Gardner Law on

In FDA regulatory matters, companies must carefully choose when to challenge the government, and when to comply. In a recent case, Whoop, the Boston-based wearable maker, has chosen to openly challenge the U.S. Food and Drug...more

Morgan Lewis - As Prescribed

Vaccine Suspension: FDA Leans Into Its Withdrawal Toolbox, But Will It Invite Challenges?

On August 22, 2025, FDA suspended the biologics license for Ixchiq, one of only two marketed chikungunya vaccines. The decision to suspend comes only a few weeks after FDA approved a Safety Labeling Change supplemental...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit: Patent Must Claim Active Ingredient for Orange Book Listing

On December 20, 2024, the U.S. Court of Appeals for the Federal Circuit issued a significant ruling in the Teva v. Amneal case following oral arguments before the Federal Circuit, which we discussed in our previous article. ...more

McDermott Will & Schulte

Post-Chevron Insights and Resources

On June 28, 2024, in Loper Bright Enterprises v. Raimondo, the US Supreme Court overruled the decades-old Chevron doctrine. This decision means that courts must now determine the meaning of federal statutes and effectively...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

Husch Blackwell LLP

The Overturning of Chevron Deference: Implications for AI in Medical Research

Husch Blackwell LLP on

In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more

Schwabe, Williamson & Wyatt PC

Chevron’s End Means Uncertainty and Opportunity for the Healthcare Industry

“Chevron is overruled.” The U.S. Supreme Court’s June 28 decision in Loper Bright Enterprises v. Raimondo and its companion case, Relentless v. Department of Commerce, will have enormous effects on the healthcare sector....more

Akin Gump Strauss Hauer & Feld LLP

Chevron Runs Out of Gas: The Bumpy Road Ahead for Health Regulations After Loper Bright

On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more

Foley Hoag LLP

Chevron’s Demise—And What It Means for Healthcare and Life Sciences Companies

Foley Hoag LLP on

Since 1984, the “Chevron doctrine” had served as the bedrock of many regulatory actions by the U.S. Department of Health and Human Services (HHS) and other federal agencies. Under the doctrine, courts followed a two-step...more

Axinn, Veltrop & Harkrider LLP

Ready for the Flood of Litigation Against Federal Agencies?

Yesterday, the Supreme Court heard oral arguments in two related cases that may have a significant impact on litigation against federal agencies – Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce....more

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