FDA Wants To Lead Global Efforts To Include Pregnant Women In Trials

FDA officials say a major paradigm shift is needed to make sure pregnant and breastfeeding women are included in clinical trials, and the agency hopes to lead efforts among stakeholders and the international regulatory community to develop a roadmap for change. The agency officials are working with their colleagues from the European Medicines Agency and the United Kingdom’s Medicines and Healthcare products Regulatory Agency to highlight opportunities for change in collection and use of nonclinical, clinical and postmarket data. “We...