After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
10/11/2023
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CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
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The U.S. Food & Drug Administration (FDA) previously issued emergency use authorizations (EUA) and adopted emergency policies in response to the COVID-19 public health emergency (PHE) to facilitate the availability of key...more