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USFDA Statement: New Patient Medication Information - Medication Guide for Patients

Yesterday (31 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research (CDER) proposed a new New, Easy-to-Read Medication Guide for Patients: "Patient Medication Information".

A Medication Guide is FDA-approved written patient prescription drug product information for certain prescription drug products that are used primarily on an outpatient basis.

As of now, patients can receive one or more types of written prescription drug product information in outpatient settings once they have been prescribed a prescription medication, including the following:

  1. Patient Packaging Insert (PPI)

  2. Medication Guides

  3. Consumer Medication Information

  4. Instructions for Use.

In response to patient requests, the Food and Drug Administration is proposing to amend its regulations on human prescription drug product labeling.

Once this proposal is finalized, applicants will need to prepare a new type of Medication Guide, referred to as Patient Medication Information (PMI), for prescription drugs, including biological products, that are dispensed, administered, or used on an outpatient, as well as blood and blood components transfused in an outpatient environment.

In Patient Medication Information, patients will find essential information about their prescription drug products, including instructions on how to use the product. PMI will be FDA-approved, one-page documents that follow standard content and format including:

  • Drug/Biological product name

  • Concise summary of the indications and uses

  • Important safety information

  • Common side effects

  • Directions for use

Prescription drug products would come with FDA-approved Patient Medication Information to help patients use the products safely and effectively. Patient Medication Information would be stored electronically in FDA’s labeling repository.

Click this LINK to know more about the proposed "Medication Guides: Patient Medication Information"


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