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Administrative Procedure Act Preliminary Injunctions Food and Drug Administration (FDA)

Knobbe Martens

District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List

Knobbe Martens on

Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage. For example, a determination of...more

Epstein Becker & Green

HHS Reverses Its Longstanding Policy and Limits Public Participation in Rulemaking

On March 3, 2025, the Secretary of Health and Human Services published a policy statement in the Federal Register that reverses a policy adopted over 50 years ago that was intended to expand public participation in the...more

BakerHostetler

Federal Court Blocks FDA’s Graphic Cigarette Warning Rule: The Limits of Regulatory Authority

BakerHostetler on

On Monday, a federal judge from the Eastern District of Texas, Judge J. Campbell Barker, ruled that the U.S. Food and Drug Administration (FDA) exceeded its authority under the Tobacco Control Act by requiring cigarette...more

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