FDA Proposes Toll-Free Number to Report Drug Side Effects
04/22/2004
Federal Register Proposed rule: FDA is proposing to require a statement on the labeling of approved human drug products that includes a toll-free number and advises that the number is to be used only for reporting side effects and is not intended for medical advice. The agency is also proposing to use the existing MedWatch safety information and adverse event reporting program and its toll-free number. The rule will bring FDA regulations into compliance with provisions of the Best Pharmaceuticals for Children Act. To view this proposed rule, click here.
