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Pregnancy labeling

This article was originally published in The Tan Sheet

Executive Summary

Subcommittee of FDA's Reproductive Health Drugs Advisory Committee will meet March 28-29 to consider the status of proposed pregnancy labeling changes, preclinical assessment of reproductive toxicity, FDA draft guidance on establishing pregnancy registries and strategies for monitoring drug risks in pregnant women. The subcommittee will meet at the Hilton in Gaithersburg, Md., the site of an FDA public meeting March 30 on safety concerns regarding dietary supplement use during pregnancy. Written comments on the supplement issues are due by April 24 (1"The Tan Sheet" Feb. 21, In Brief)

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FDA will hold a public meeting March 30 on safety issues related to dietary supplement use during pregnancy. In a notice to be published in the Feb. 24 Federal Register, FDA seeks comments on five points: potential maternal and fetal hazards associated with supplement use for pregnancy-related conditions; existence of certain pregnancy-related conditions for which structure/function claims should be permitted; potential harm of using supplements during pregnancy for conditions unrelated to pregnancy; means of addressing safety concerns associated with supplement use during pregnancy; and use of specific warnings on supplements for pregnancy-related conditions. The meeting is 9 a.m. to 5 p.m. at the Hilton in Gaithersburg, Md.; comments are due within 60 days of the Federal Register notice date

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