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CSPI Urges FDA To Follow “Intent” Of AER Law In Labeling Guidance

This article was originally published in The Tan Sheet

Executive Summary

The Center for Science in the Public Interest is urging FDA to require a statement on labels for OTC drugs and dietary supplements advising consumers to make any reports of any adverse reactions using telephone numbers or mailing addresses also printed on the packages

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AHPA Asks FDA To Allow Firms To Route AER Contact To Offices Outside U.S.

FDA's guidance on adverse event reporting for OTC drugs and dietary supplements should assure that firms operating outside the country can use U.S. addresses on their product labels but receive AER-related communication in their home countries, the American Herbal Products Association recommends

Adding Street Address To Product Label Likely In AER Guidance – CFSAN

FDA appears likely to include a street address recommendation in its guidance for dietary supplement and OTC product adverse event reporting, and a Center for Food Safety and Applied Nutrition executive assures industry the center is considering a guidance, not a rule

Adverse Event Collection Expected To Be In Force By Christmas 2007

Firms that make, pack or distribute dietary supplements and over-the-counter drugs approved under monographs will likely have to be in compliance with a new adverse event reporting law by late December 2007


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