Legal Opinion

Association for Molecular Pathology v. United States Food and Drug Administration PURSUANT TO COURT ORDER, DOCKET IN THE LEAD CASE AS DIRECTED.

District Court, E.D. Texas

Decided March 31, 2025No. 4:24-cv-00824Unknown

1Opinion

EASTERN DISTRICT OF TEXAS SHERMAN DIVISION AMERICAN CLINICAL § LABORATORY ASSOCIATION, § ET AL. § § v. § § CIVIL NO. 4:24-CV-479-SDJ U.S. FOOD AND DRUG § ADMINISTRATION, ET AL. § ASSOCIATION FOR § MOLECULAR PATHOLOGY, § ET AL. § § v. § CIVIL NO. 4:24-CV-824-SDJ § U.S. FOOD AND DRUG § ADMINISTRATION, § ET AL. § MEMORANDUM OPINION AND ORDER Laboratory-developed test services are in-house diagnostic tests developed, validated, and performed by trained professionals within a single clinical laboratory. They are performed on blood, urine, tissue, or other types of specimens at the request of an…

2Cases cited49 opinions

  1. Lujan v. Defenders of WildlifeSupreme Court of the United States · 1992
  2. Marbury v. MadisonSupreme Court of the United States · 1803
  3. Association of Data Processing Service Organizations, Inc. v. CampSupreme Court of the United States · 1970
  4. Lexmark Int'l, Inc. v. Static Control Components, Inc.Supreme Court of the United States · 2014
  5. Robinson v. Shell Oil Co.Supreme Court of the United States · 1997

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