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Consumers, Health Practitioners Heeded FDA’s Call For WEN-Related AEs

This article was originally published in The Rose Sheet

Executive Summary

FDA’s safety alert in July, asking WEN users and their doctors to share information regarding hair loss-related adverse events, yielded approximately 1,000 reports in just over two months, contributing to a massive increase in cosmetic AE reports for FY 2016.

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In a Q&A posting, FDA Office of Cosmetics and Colors Director Linda Katz offered perspective on how the division handles adverse event reports and makes a case for mandatory AE reporting. She also explains how FDA reacted when WEN-related AERs began rolling in.

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WEN Will Guthy-Renker, Chaz Dean Put Hair-Loss Ordeal Behind Them?

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