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Federal Food Drug and Cosmetic Act (FFDCA) HELP

Mintz - Health Care Viewpoints

The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule

The U.S. Food and Drug Administration (FDA) recently released a proposed rule that would seek to regulate laboratory developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA). This rule...more

King & Spalding

Act II: The Senate Unveils Its Draft

King & Spalding on

On May 27, 2022, Senate Health, Education, Labor, and Pensions (“HELP”) Committee leaders introduced the Food and Drug Administration Safety and Landmark Advancements Act of 2022 (“FDASLA Act of 2022”), which, if passed,...more

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