Executive Summary

PREGNANCY LABELING CATEGORY REVISIONS UNDER CONSIDERATION by FDA, according to Metabolism and Endocrine Drug Products Division Director Solomon Sobel, MD. Speaking at an FDA-sponsored conference on regulated products and pregnant women on Nov. 7-8 in Crystal City, Va., Sobel reported that an ad hoc panel of pharmacologists and toxicologists has been active for about one year developing recommendations for FDA on whether changes to the current system are needed and how they should be accomplished. The panel's recommendations would require approval by FDA's office and division directors and would go through a formal notice and comment period.