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# Postapproval Pregnancy Safety Studies Guidance Available
- URL: https://www.fdaweb.com/postapproval-pregnancy-safety-studies-guidance-available/
- Published: 2026-05-08T12:00:00.000Z
- Updated: 2026-09-14T13:38:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161115

FDA has released [new guidance ](https://www.fda.gov/media/124746/download?ref=fdaweb.com)outlining how drugmakers should design and conduct postapproval studies evaluating the safety of medicines and biologics used during pregnancy, emphasizing the growing importance of real-world evidence and postmarketing surveillance in maternal-fetal health. The guidance, *Postapproval Pregnancy Safety Studies*, provides recommendations for sponsors and investigators on assessing pregnancy outcomes among women exposed to FDA-regulated drugs and biologics after products reach the market.

The agency notes that pregnant women remain significantly underrepresented in preapproval clinical trials, leaving substantial gaps in safety information at the time many therapies enter the market. As a result, FDA says postmarketing data collection is critical for identifying potential risks to pregnant patients and developing fetuses.

“Pregnant women were historically excluded from clinical studies to protect fetuses from potentially harmful exposures,” the guidance states. “However, this exclusion results in a shift of risk to the postmarketing setting where there may be widespread use.”

FDA cites national statistics showing roughly 3.6 million births occur annually in the U.S. and notes that many pregnant patients require treatment for chronic conditions such as diabetes, epilepsy, and asthma, or may need acute therapies and vaccines during pregnancy. The agency also highlighted that more than 41% of U.S. pregnancies in 2019 were unintended, increasing the possibility of inadvertent fetal drug exposure before pregnancy is recognized.

The guidance explains that FDA can require postmarketing studies or clinical trials under Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act when necessary to assess known or potential serious risks associated with drug exposure during pregnancy.

FDA identifies three key periods for potential pregnancy-related safety monitoring: exposure before conception, exposure during pregnancy, and postpartum monitoring after delivery. The agency notes that medications may affect fertility, implantation, miscarriage risk, maternal disease progression, fetal development, or postpartum recovery depending on the product and timing of exposure.

The document places substantial emphasis on observational research approaches, including pregnancy registries, pharmacoepidemiologic studies, case reports, and complementary real-world data sources. FDA said these approaches can collectively provide evidence on maternal, fetal, and infant outcomes associated with product exposure.

Pregnancy registries were described as a particularly important postmarketing tool because they prospectively enroll women before pregnancy outcomes are known, allowing more accurate assessment of exposure timing, dosage, and confounding factors. However, FDA acknowledges that registries often struggle with enrollment and may not alone provide sufficient statistical power to evaluate rare adverse outcomes.