The Food and Drug Administration yesterday published draft guidance to promote clinical studies to increase drug safety information for pregnant and nursing women and their providers.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 The agency will accept comments on the draft guidance through July 8.

Related News Articles

Perspective
In Michigan, African Americans make up 14% of the population … but account for 40% of the COVID-19 deaths. In Chicago: 30% of the population … and 46% of the…
Headline
The Centers for Disease Control and Prevention yesterday issued revised guidance for pediatric clinicians on caring for newborns with confirmed or suspected…
Headline
The Centers for Disease Control and Prevention yesterday issued a health advisory warning of COVID-19-associated multisystem inflammatory syndrome in children…
Headline
A new AHA resource shares ways hospitals and health systems are caring for mothers and babies during the COVID-19 crisis. The resource examines labor and…
Headline
The Centers for Disease Control and Prevention today reported a notable drop in routine childhood vaccines ordered and administered through the federal…
Headline
The Department of Health and Human Services’ Office of Minority Health May 1 announced it will provide funding to help deliver important COVID-19-related…