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FDA Proposes New Patient Medication Guide

Recently, the U.S. Food and Drug Administration ("FDA") proposed an amendment to its human prescription drug labeling regulations that would require a new type of Medication Guide for prescription drug products used, dispensed, or administered on an outpatient basis.

This "Patient Medication Information" would be an FDA-approved, one-page document that follows standardized format and content requirements. Patient Medication Information would be given to patients with their prescription drug products, providing essential information about the drug and basic directions on how to use it. Evidence suggests that such information can help patients use their prescription drug products more safely and effectively, which may reduce preventable adverse drug reactions and improve health outcomes.


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