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  • October 7, 2026
  • Last Update July 17, 2026 9:28 pm
  • United States of America

Could the FDA take an indirect approach to regulate LDTs?

Could the FDA take an indirect approach to regulate LDTs?

Attorneys said many questions remain about the regulation of laboratory developed tests after the FDA lost its legal fight. A recent warning letter could be a clue to future enforcement.

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