Proposed FDA Rule Will Create “Patient Medical Information”

Published: 04/19/2024

Sources:
  • Food and Drug Administration
Relevant To:
  • All Healthcare Organizations

In May 2023, the U.S. Food and Drug Administration (FDA) issued a proposed rule to amend its human prescription drug product labeling regulations for Medication Guides that, if finalized, will require a new type of information known as Patient Medication Information (PMI).

PMI is a new type of Medication Guide proposed by FDA, designed to provide concise, easy-to-understand information about prescription medicines for patients.

According to a new update from the FDA, patients often receive

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