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Life Sciences › Preemption › Federal Food Drug and Cosmetic Act (FFDCA)

McDermott Will & Schulte

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

McDermott Will & Schulte on

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more

Harris Beach Murtha PLLC

Medical and Life Sciences: New York 2024 Year in Review

Harris Beach Murtha PLLC on

From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more

Morrison & Foerster LLP - Left Coast Appeals

This Week at the Ninth: Implied FDCA Preemption

Morrison & Foerster LLP - Left Coast Appeals on

This week, the Ninth Circuit addresses the statutory prohibition on private enforcement actions under the Food, Drug, and Cosmetic Act. The Court holds that a drug manufacturer’s suit against a compounding pharmacy for...more

Quarles & Brady LLP

The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think

Quarles & Brady LLP on

On February 4, 2022, the FDA released its long-awaited proposed national standards for the licensure of third party logistics providers (3PLs) and wholesale drug distributors. The draft rules were years over-due and the delay...more

Hogan Lovells

New FDA proposed rule will eventually preempt state drug wholesaler/3PL licensure laws

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced the proposed rule, “National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers,” which aims to improve the security...more

Harris Beach Murtha PLLC

New York Medical and Life Sciences: Year in Review 2021

Harris Beach Murtha PLLC on

From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more

Troutman Pepper Locke

Right to Try Legislation: Worthwhile or Window Dressing?

Troutman Pepper Locke on

"Right to Try" legislation, which enables terminally ill patients or patients with a "life threatening disease or condition" to seek access to investigative drugs with little to no oversight from the FDA, has been enacted in...more

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