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Food and Drug Administration (FDA) OIRA Final Rules

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FDA’s Laboratory Developed Test (LDT) Final Rule Under OIRA Review

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On March 1, 2024, the Office of Information and Regulatory Affairs (“OIRA”), Office of Management and Budget (“OMB”), Executive Office of the President received the final version of FDA’s rule on regulation of laboratory...more

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FDA Targets April 2024 for Laboratory Developed Test (LDT) Final Rule

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On December 6, 2023, the Office of Information and Regulatory Affairs (“OIRA”) released the Fall 2023 Unified Agenda of Regulatory and Deregulatory Actions (the “Agenda”), a semiannual compilation of information regarding...more

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