• Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
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    UK Regulators Prepare for Review of 'Forgotten Thalidomide'

    Regulators in the UK are asking the public to report “suspected adverse effects” of hormonal pregnancy tests (HPTs), which have been off the market in the UK since the late 1970s after being associated with serious birth defects and miscarriages. The information will be used as part of an independent review to determine whether there is a causal relationship between HPT use and reported side effects. MHRA is asking for submissions by 30 June 2015, and says the repo...
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    FDA Scraps Pregnancy Labeling Classification System in Favor of New Standard

    The labeling on many prescription drug products approved after 2001 will need to be reconfigured to include clearer information about whether a drug is safe to use during pregnancy, the US Food and Drug Administration (FDA) announced today. Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce labeling uniformity were first passed. Those measures were substantially updated in 2006 under FDA's ...
  • 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...