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Food and Drug Administration (FDA) OIRA Clinical Laboratories

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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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