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The New FDA Pregnancy Labeling Requirements for Drugs


  • Marilynn C. Frederiksen MD

Address correspondence to Marilynn C. Frederiksen, MD, Associate Professor of Clinical Obstetrics and Gynecology, Feinberg Medical School of Northwestern University, 680 N Lake Shore Dr, Suite 1428, Chicago, IL 60611. E-mail:


The new US Food and Drug Administration Proposed Rules for pharmaceutical products for the special population of pregnant women were published in May 2008. With these new rules in place, clinicians caring for women who are pregnant may begin to have clearer and more relevant information in the product label to guide clinical decisions regarding drug use during pregnancy.