Guidance for Reviewers on Evaluating the Risks of Drug Exposure in Human Pregnancies; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a guidance for reviewers entitled "Reviewer Guidance: Evaluating the Risks of Drug Exposure in Human Pregnancies." This guidance is intended to help FDA staff evaluate human fetal outcome data generated after medical product exposures during pregnancy. The goal of such evaluations is to assist in the development of product labeling that is useful to medical care providers when they care for patients who are pregnant or planning pregnancy. The review of human pregnancy drug exposure data and assessment of fetal risk (or lack of risk) requires consideration of human embryology and teratology, pharmacology, obstetrics, and epidemiology. Consequently, FDA staff also are encouraged to consult with experts in these fields, as appropriate. The guidance announced in this document finalizes the draft guidance entitled "Guidance for Reviewers: Evaluation of Human Pregnancy Outcome Data" announced in the Federal Register of June 4, 1999.