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Outside the Lab Regulation and standards, Quality assurance and quality control, Laboratory management, Technology and innovation, Clinical care

FDA LDT Guidance Delayed

Laboratory developed tests (LDTs) in the US have long been under the jurisdiction of the Clinical Laboratory Improvement Law – which covers laboratory regulations in general. From vitamin assays to tests for genetic mutations, as long as the in vitro LDTs were designed, manufactured, and used within a single laboratory, there were no regulatory issues. That is, until the FDA got involved…

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About the Author

William Aryitey

My fascination with science, gaming, and writing led to my studying biology at university, while simultaneously working as an online games journalist. After university, I travelled across Europe, working on a novel and developing a game, before finding my way to Texere. As Associate Editor, I’m evolving my loves of science and writing, while continuing to pursue my passion for gaming and creative writing in a personal capacity.

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