Crafting an Effective Pregnancy Exposure Registry Action Plan

Safety data on products taken by pregnant women lags considerably behind reporting for other conditions. As such, sponsors, mandated by 2015 FDA guidelines on pregnancy and lactation draft labeling, increasingly require such data in order to write draft labels on pregnancy risk.

In this whitepaper, UBC discusses pregnancy exposure registries (PERs) as an approach to discerning data on the safety and efficacy of a product for a woman and her offspring thus allowing sponsors to better manage risk.