Public Interest Groups Urge FDA To Regulate Laboratory-Developed Tests If Congress Will Not Act

Commissioner Says Agency Will ‘Move Forward’ Alone Even as It Continues To Work With Legislators
Dennis Tosh
June 1, 2023 at 11:16 AM EST
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A group of 16 public interest organizations has written to Commissioner of Food and Drugs Dr. Robert M. Califf to urge the FDA “to develop regulations for laboratory-developed tests (LDTs) in the event that legislation to regulate such tests does not progress in Congress.” In a May 30 letter, the organizations applauded the FDA’s past actions to regulate LDTs and urged the ag... Read More