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AER Label Guidance Holds To Requiring Full Addresses For OTCs, Supplements

This article was originally published in The Tan Sheet

Executive Summary

FDA is extending the deadline for serious adverse event labeling requirements for OTC drugs and dietary supplements until January 2010 because it has yet to finalize its guidance to comply with those regulations

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Supplement Firms Have ‘Continuous Monitoring’ Burden To Show Product Safety

Former FDA supplement programs head Bill Frankos says the industry bears the burden for monitoring product safety in the marketplace because FDA does not have the same vested interest it has for drugs and medical devices stemming from pre-market approval of the products.

Supplement Firms Have ‘Continuous Monitoring’ Burden To Show Product Safety

Former FDA supplement programs head Bill Frankos says the industry bears the burden for monitoring product safety in the marketplace because FDA does not have the same vested interest it has for drugs and medical devices stemming from pre-market approval of the products.

Supplement Firms Have ‘Continuous Monitoring’ Burden To Show Product Safety

Former FDA supplement programs head Bill Frankos says the industry bears the burden for monitoring product safety in the marketplace because FDA does not have the same vested interest it has for drugs and medical devices stemming from pre-market approval of the products.

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