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Gardner Law

From Discretion to Regulation: FDA's New Path for LDTs

Gardner Law on

Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more

Foley & Lardner LLP

FDA Laboratory Developed Test Oversight: What Stakeholders Need to Know About Proposed Overhaul

Foley & Lardner LLP on

After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more

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