District Court Rules FDA Lacks Authority to Regulate Laboratory Developed Tests Topic of White Paper From CRS
May 11, 2025
May 11, 2025
WASHINGTON, May 11 -- The Congressional Research Service issued the following Legal Sidebar white paper (No. LSB11312) on May 9, 2025, by legislative attorneys Dorothy C. Kafka and Wen W. Shen:
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On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled - in two consolidated cases, American Clinical Laboratory Association (ACLA) v. FDA and Association for Molecular Pathology (AMP) v. FDA - that the Food and Drug Administration (FDA) lacks st . . .
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On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled - in two consolidated cases, American Clinical Laboratory Association (ACLA) v. FDA and Association for Molecular Pathology (AMP) v. FDA - that the Food and Drug Administration (FDA) lacks st . . .