> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Draft Guidances on Drugs in Pregnancy, Lactation
- URL: https://www.fdaweb.com/fda-draft-guidances-on-drugs-in-pregnancy-lactation/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144059

FDA is issuing two draft guidances that, when finalized, will provide new and updated information for companies designed to increase the availability of high-quality safety information on drugs used during pregnancy or lactation. The [first draft](https://www.federalregister.gov/documents/2019/05/09/2019-09528/guidance-clinical-lactation-studies-considerations-for-study-design?ref=fdaweb.com), *Clinical Lactation Studies: Considerations for Study Design*, gives agency recommendations for sponsors on conducting lactation studies. The draft builds upon a 2005 guidance and streamlines and simplifies recommendations for sponsors on these types of studies, FDA says.

The agency says that in developing the guidance it factored in discussions at advisory committees and public workshops that considered how data from such studies can inform the safety of a drug when used during lactation, including whether it’s passed through breastmilk to a nursing infant, or there are changes in a woman’s body as a result of her lactation that could otherwise affect the safety or efficacy of a drug.

The [second draft](https://www.federalregister.gov/documents/2019/05/09/2019-09527/guidance-postapproval-pregnancy-safety-studieshttps:/www.federalregister.gov/documents/2019/05/09/2019-09527/guidance-postapproval-pregnancy-safety-studies?ref=fdaweb.com), *Postapproval Pregnancy Safety Studies*, outlines recommendations on how to design studies and leverage other forms of data, including real-world data, to assess the outcomes of pregnancies in women taking FDA-regulated drugs and biological products during pregnancy. The draft broadens the scope of methods used in collection of safety information for drugs and biological products used during pregnancy to include database studies such as claims or electronic health records, case-control studies, population-based surveillance, and other pharmacovigilance methods. When finalized, the draft will replace a 2002 guidance.

In an agency [statement](https://www.fda.gov/news-events/press-announcements/statement-principal-deputy-commissioner-amy-abernethy-md-phd-and-janet-woodcock-md-director-fdas?ref=fdaweb.com), principal deputy commissioner **Amy Abernethy** and CDER director **Janet Woodcock** say the two guidances are consistent with the recommendations made by the Task Force on Research Specific to Pregnant Women and Lactating Women that was established by the Cures Act to identify and report on gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. “The draft guidances are an additional step the agency is taking toward getting women who are pregnant or breastfeeding important safety information about their medications, so they can make informed decisions about their health and the health of their babies,” Abernethy and Woodcock say.