Friday - July 18, 2025
District Court Rules FDA Lacks Authority to Regulate Laboratory Developed Tests Topic of White Paper From CRS
June 07, 2025
WASHINGTON, June 7 (TNSLrpt) -- The Congressional Research Service issued the following Legal Sidebar white paper (No. LSB11312) on May 19, 2025, by legislative attorneys Dorothy C. Kafka and Wen W. Shen:

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District Court Rules FDA Lacks Authority to Regulate Laboratory Developed Tests

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 . . .

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