American Clinical Laboratory Association et al v. U.S. Food and Drug Administration et al
Case Number:
4:24-cv-00479
Court:
Nature of Suit:
Other Statutes: Administrative Procedures Act/Review or Appeal of Agency Decision
Judge:
Firms
- Covington & Burling
- Griffith Barbee
- Hyman Phelps
- King & Spalding
- Mills Shirley
- O’Connell & Aronowitz
- Sidley Austin
- Tenenbaum Law (Greenwood Village, CO)
- Tenenbaum Law Group
Companies
- American Clinical Laboratory Association
- American Society for Clinical Pathology
- Center for Science in the Public Interest
- Competitive Enterprise Institute
- Public Citizen Inc.
Government Agencies
Sectors & Industries:
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March 31, 2025
Texas Judge Deems Lab-Test Rule Outside FDA Authority
A Texas federal judge on Monday vacated a new U.S. Food and Drug Administration rule that would have brought lab-developed tests under its regulatory authority as "medical devices," finding that the move exceeded the agency's statutory authority and defied "common sense."
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September 04, 2024
Trade Group Urges Court To Toss FDA Lab-Test Rule
A clinical-lab trade group and an infectious disease laboratory that sued the U.S. Food and Drug Administration over its new final rule on laboratory-developed tests are asking a federal court to vacate it, saying Congress didn't grant the agency such power.
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May 29, 2024
FDA Sued Over Controversial Lab Test Rule
A clinical lab trade group that has been highly critical of the U.S. Food and Drug Administration's new final rule on laboratory-developed tests filed a lawsuit late Wednesday, saying the agency doesn't have the authority to regulate the tests as medical devices.