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Federal Food Drug and Cosmetic Act (FFDCA) Regulatory Oversight CLIA

Akin Gump Strauss Hauer & Feld LLP

FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set to be officially published on May 6, this...more

Paul Hastings LLP

A Sea Change Looms as FDA Finalizes Its Controversial Regulation Asserting Jurisdiction Over LDTs

Paul Hastings LLP on

On April 29, 2024, after years of false starts trying to expand oversight of laboratory developed tests (“LDTs”) through administrative and legislative actions, FDA announced the much-anticipated—and highly...more

ArentFox Schiff

FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

ArentFox Schiff on

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to...more

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