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  • Regulatory NewsRegulatory News

    FDA Finalizes HIV Drug Development Guidance

    The US Food and Drug Administration (FDA) has added more detailed definitions for treatment-naïve and treatment-experienced HIV patients and provides recommendations for designing switch trials, according to guidance finalized Monday. The agency hopes the guidance will "promote and facilitate more drug development in the heavily treatment-experienced population," an FDA spokesman told Focus , by introducing a trial design using "an endpoint of virologic efficacy within ...
  • Ireland: HIQA Releases Economic Evaluation of Repeat Universal Antenatal Screening for HIV in the Third Trimester of Pregnancy

    A report issued by Ireland's Health Information and Quality Authority (HIQA) contains advice on whether a change in the existing Irish guidelines for the management of human immunodeficiency virus-1 (HIV-1) in pregnancy is warranted. The conclusion is that the cost of introducing repeat universal antenatal HIV screening in the third trimester is high compared to the expected benefits. In the context of a finite healthcare budget, consideration must be given to the e...