FDA Launches New Medication Guide Database

PUBLISHED: Aug 13, 2018
Relevant to: All Healthcare Organizations

The US Food and Drug Administration (FDA) has launched a new Medication Guide database to replace the current Medication Guide web page. A medication Guide is a form of patient labeling that is part of the FDA-approved prescription drug labeling. The FDA requires that Medication Guides be issued with certain prescribed drugs and biological products when the Agency determines that:

  • Certain information is necessary to prevent serious adverse effects
  • Patient decision-making should be informed by information about a known serious side effect with a product, or
  • Patient adherence to directions for the use of a product are essential to its effectiveness.

Medication Guides address issues that are specific to particular prescription drugs or biologic products and can help patients avoid serious adverse events.

Features of the new medication guide database include:

  • Active ingredient and brand name search for medication guides,
  • Download capabilities to CSV and Excel spreadsheets,
  • Streamlined data entry for faster database updates and,
  • Improved mobile device usability.

Follow the link below to access the new medication guide database.

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