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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Labeling Made Simple: The How, What, and Where of Drug Interactions in Prescribing Information

Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Fri, 4/1/22: 12:00 AM EDT
Ends On: Sun, 12/31/23: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This webinar provided an overview of the evolution of prescribing information (PI) format and content, key regulations impacting drug interaction (DI) content in the PI, and the regulatory science behind, including essential DI information in the PI. In addition, alternative display methods to enhance readability and utility as well as unique DI related content (e.g., in vitro information, modeling and simulation, and complex DI scenarios) was also discussed.
Objectives:
  • Identify key regulations that impact drug interaction content in prescribing information (PI)
  • Locate drug interaction content in the PI
  • Discuss the content structure of the DRUG INTERACTIONS section in PI
  • Identify alternative methods of communicating complex drug interaction content
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: LabelingMadeSimpleSlides