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CDER guidance agenda

This article was originally published in The Tan Sheet

Executive Summary

"Minimum Data Elements to be Included in a Serious Adverse Event Report for Monograph OTC Products" and "Labeling Dietary Supplements for Women Who Are or Could Be Pregnant," are two of 40 guidances the Center for Drug Evaluation and Research plans to develop during 2007. According to the March 19 1document, the agenda items are guidances "under development as of the date of this posting." Other guidances listed include: "Labeling of Over-the-Counter Skin Protectant Drug Products," "Drug Interaction Studies - Study Design, Data Analysis and Implications for Dosing and Labeling" and "Individual Product Bioequivalence Recommendations." Several of the guidances under development have previously been listed in annual guidance agendas, including "Labeling Dietary Supplements for Women Who Are or Could Be Pregnant," which has been listed since 2004...
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