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Business · 22/04/2004

FDA Proposes Rule Requiring Toll-Free Number for Reporting Adverse Events on Human Drug Labels

The FDA is proposing to add a toll-free number to labeling for human drug products, which will be used only for reporting side effects and not for medical advice, in compliance with the Best Pharmaceuticals for Children Act.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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