Toll-Free AER Number For Sec. 505 OTCs To Be On Labels One Year After Rule

This article was originally published in The Tan Sheet

26 Apr 2004
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The Tan Sheet

Executive Summary

FDA is planning to allow OTCs approved under an NDA or ANDA up to one year to add a toll-free number to labeling for adverse event reports, according to a 1proposed rule published in the April 22 Federal Register

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OTC Drugs

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Toll-Free AER Number For Sec. 505 OTCs To Be On Labels One Year After Rule

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