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Judicial Review Appeals Food and Drug Administration (FDA)

Knobbe Martens

U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products

Knobbe Martens on

We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product. On April 2, 2025, the Supreme Court of the United States...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

McDermott Will & Emery

Federal Court Strikes Down LDT Final Rule

On March 31, 2025, the US District Court for the Eastern District of Texas struck down the US Food and Drug Administration’s (FDA) final rule under which FDA would have started regulating most laboratory-developed tests...more

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