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Guidance on Adding Toll-Free Number to Med Guides

06/08/2009

Federal Register Notice: FDA is making available a guidance for industry, Medication Guides —Adding a Toll-Free Number for Reporting Adverse Events. Beginning 7/1, 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 and report to the agency that they have complied with this requirement. To download this guidance, click here. To view this notice, click here.

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