Business · 28/10/2008Updated: 10/17/2026 · 1 min read

FDA Issues Final Rule on Toll-Free Number for Reporting Adverse Events on Human Drug Labels

The FDA is confirming a rule requiring certain human drug products to include a toll-free number for reporting side effects, as mandated by the Best Pharmaceuticals for Children Act and the Food and Drug Administration Amendments Act of 2007, and implementing this rule through a final rule published on January 3, 2008.