FDA Takes New Steps to Bolster Research on Pregnant and Lactating Women

May 8, 2019

(STAT News) – F ederal health officials on Wednesday rolled out two new draft guidances about how to study drug safety and efficacy in pregnant and lactating women, the latest in a series of steps to make sure women have the information they need to make medical decisions. The draft documents, released by the Food and Drug Administration, give drug makers insight into the agency’s thinking on when they should study a medicine in lactating women and how they can better monitor outcomes in pregnant women who are taking medications that have already been approved.