Global regulators are calling for a paradigm shift in clinical research and urging pharma to include pregnant and breastfeeding women in their studies in order to “address inadequacies in research”.
In a statement, various stakeholders at the US Food and Drug Administration (FDA) asserted that too often pregnant and breastfeeding women, along with their health care providers, are left to make important clinical decisions on the basis of little to no data on the safety or effectiveness of medications used during and shortly after pregnancy. This, they said, is true even for serious medical conditions like asthma, epilepsy, depression and COVID-19.
