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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

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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A rule mandated by the FDA reauthorization Congress passed in 2007 that requires a toll-free number for reporting side effects on packaging for non-monograph OTC products and all Rx drugs went into effect Jan.1, but the agency likely will not enforce it until 2009

FDAAA Requires Toll-Free Number For Side Effect Reports On Application OTCs

A rule mandated by the FDA reauthorization Congress passed in 2007 that requires a toll-free number for reporting side effects on packaging for non-monograph OTC products and all Rx drugs went into effect Jan.1, but the agency likely will not enforce it until 2009

FDAAA Requires Toll-Free Number For Side Effect Reports On Application OTCs

A rule mandated by the FDA reauthorization Congress passed in 2007 that requires a toll-free number for reporting side effects on packaging for non-monograph OTC products and all Rx drugs went into effect Jan.1, but the agency likely will not enforce it until 2009

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