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to consider the status of proposed pregnancy labeling changes, preclinical assessment of reproductive toxicity, FDA draft guidance on establishing pregnancy registries and strategies for monitoring drug risks in pregnant women.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)