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Expert Gives Lowdown On Adverse Event Reporting Bill For Monograph OTCs

This article was originally published in The Rose Sheet

Executive Summary

The compliance of companies newly subject to adverse event reporting and record-keeping requirements will likely be evaluated by FDA on a "performance-oriented basis," said Rick Kingston, PharmD, president and senior clinical toxicologist at SafetyCall International, an adverse event call center

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"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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"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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