FDAAA Requires Toll-Free Number For Side Effect Reports On Application OTCs
This article was originally published in The Tan Sheet
Executive SummaryA 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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