The FDA has released guidance on “Medication Guides: Adding a Toll-Free Number for Reporting Adverse Events.” Beginning July 1, 2009, manufacturers of prescription drug products approved under the Federal Food, Drug, and Cosmetic Act that are required to have a Medication Guide must add a verbatim statement to their Medication Guides containing FDA’s toll-free number for reporting side effects. These manufacturers also must report to FDA that they have complied with this requirement. This guidance explains what statement to add to Medication Guides, where to add it, and how to notify the agency that such a statement has been added.
