The draft guidance on "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials" has issued today and is available at: 

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM603873.pdf

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.  The draft guidance is open for public comment until June 8, 2018.  The Federal Register Notice is: https://www.regulations.gov/document?D=FDA-2018-D-1201-0001