Pharma/Biotech – USA, Europe, Asia and ROW Regulatory News – June 2024
Stay informed with the latest regulatory news in Pharma and Biotech for June 2024, covering the USA, Europe, Asia, and the rest of the world. Key updates include FDA authorizations, EMA recommendations.
The U.S. Food and Drug Administration granted marketing authorization to Cepheid for the Xpert HCV test and GeneXpert Xpress System, the first hepatitis C virus (HCV) test that can be used to bring diagnosis to appropriately certified point-of-care settings for individuals at risk for hepatitis C. The test may be performed in settings operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, such as certain substance use disorder treatment facilities, correctional facilities, syringe service programs, doctor’s offices, emergency departments and urgent care clinics.
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- Last Updated
- July 24, 2024