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# Pregnancy Safety Studies Draft Guide
- URL: https://www.fdaweb.com/pregnancy-safety-studies-draft-guide/
- Published: 2019-05-09T12:00:00.000Z
- Updated: 2026-09-15T01:25:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144070

*Federal Register* notice: FDA has made available a draft guidance entitled “Postapproval Pregnancy Safety Studies” that provides recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-05-09/pdf/2019-09527.pdf?ref=fdaweb.com).