FDA issues guidance to increase drug safety data for pregnant women

The Food and Drug Administration yesterday published draft guidance to promote clinical studies to increase drug safety information for pregnant and nursing women and their providers. One document provides recommendations to facilitate studies to inform drug labeling for breastfeeding women. The other document includes recommendations on how to design studies to assess pregnancy outcomes in women taking FDA-regulated drugs and biological products during pregnancy. FDA said the recommendations are consistent with those of the task force created by the 21st Century Cures Act to identify and report on drug safety research and knowledge gaps for pregnant and nursing women. The agency will accept comments on the draft guidance through July 8.