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BioWorld - Friday, July 18, 2025
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Home » Hillebrenner says FDA no longer waiting on Congress for LDT regulation
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ACLA Annual Meeting

Hillebrenner says FDA no longer waiting on Congress for LDT regulation

March 1, 2023
By Mark McCarty
The question of the U.S. FDA’s authority to regulate lab-developed tests (LDTs) has been percolating for more than a decade, but the recent failure of Congress to pass legislation granting the agency explicit authority to do so is seen in some quarters as a missed opportunity. The FDA’s Elizabeth Hillebrenner said that while the agency would prefer to regulate LDTs under new statutory authorities, the agency sees a public health problem with the current state of affairs, and thus, “we are moving forward with rulemaking.”
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