FDA’s Center for Drug Evaluation and Research issues a small entity compliance guide for labeling Rx and OTC drug products with toll-free phone numbers through which consumers can report adverse events. The guidance document, posted June 14, reminds drug makers that OTCs marketed via approved applications can specify their own toll-free number or the agency’s AER line, 1-800-FDA-1088. This requirement was part of the FDA Amendments Act of 2007 and laid out by FDA in a November 2008 final rule Also see "FDAAA Requires Toll-Free Number For Side Effect Reports On Application OTCs" - Pink Sheet, 21 January, 2008.. By contrast, monograph OTCs must be labeled with a domestic address or phone number for reporting AEs, per the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.
In Brief
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