Tag: LDT

Tax Code, Regulations and Guidance

FDA’s Proposed Rule on LDT Regulation and the Debate over Agency Deference

October 18, 2023

Via: LexBlog

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for Laboratory Developed Tests (“LDTs”).[1] The LDT regulatory status is long and meandering—and summarized below—but, […]