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Constitutional Challenges › Centers for Medicare & Medicaid Services (CMS) › Judicial Review

Goodwin

Third Circuit Affirms Rejection of AstraZeneca’s Challenges to IRA Drug Price Negotiation Program

Goodwin on

On May 8, 2025, the Court of Appeals for the Third Circuit affirmed the district court’s dismissal of AstraZeneca’s challenges to the Inflation Reduction Act’s Drug Price Negotiation Program and CMS’s Guidance implementing...more

Mintz - Health Care Viewpoints

Appeals Court Rejects AstraZeneca’s Challenge to Medicare Drug Price Negotiation Program

Mintz - Health Care Viewpoints on

A federal appellate court has handed down the first appellate-level decision addressing the merits of drug manufacturers’ challenges to the Inflation Reduction Act of 2022's (IRA) Medicare Drug Negotiation Program...more

ArentFox Schiff

FDA’s Attempt to Regulate Lab-Developed Tests Struck Down in Federal Court

ArentFox Schiff on

On March 31, a judge in the Eastern District of Texas vacated the US Food and Drug Administration’s (FDA) rule that sought to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and...more

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