News & Analysis as of

Loper Bright Enterprises v Raimondo Appeals Food and Drug Administration (FDA)

McGuireWoods LLP

Court Strikes Down FDA Rule Regulating Laboratory-Developed Tests

McGuireWoods LLP on

On March 31, 2025, the U.S. District Court for the Eastern District of Texas, in American Clinical Laboratory Association v. U.S. Food and Drug Administration, vacated the U.S. Food and Drug Administration’s (FDA’s) May 6,...more

Epstein Becker & Green

The LDT Final Rule Bites the Dust: Examining the Repercussions of the Federal Court’s Vacatur and What the Future May Hold

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests...more

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