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CDER guidance agenda

This article was originally published in The Rose Sheet

Executive Summary

"Minimum Data Elements to be Included in a Serious Adverse Event Report for Monograph OTC Products" is one of 40 guidances the Center for Drug Evaluation and Research plans to develop during 2007. According to the March 19 release, the agenda items are "under development as of the date of this posting." Sunscreens, antiperspirants and treatments for dandruff and acne are among products regulated under FDA over-the-counter monographs. The "Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006" (S 3546), signed into law in late 2006 and effective in December, establishes mandatory reporting of serious adverse events associated with such products (1"The Rose Sheet" Jan. 29, 2007, p. 7). The list of guidances includes "Labeling of Over-the-Counter Skin Protectant Drug Products"...

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