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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

Tips to Navigating Drug Interaction information in the US Prescribing Information

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Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Wed, 5/15/24: 12:00 AM EDT
Ends On: Fri, 5/14/27: 12:00 AM EDT
Type: Enduring Material
Credits: 1
Description: This presentation will provide an overview of the format and content of the drug interaction (DI) information contained within the prescribing information (PI) and outline the important regulations that impact labeling development. In addition, recently published FDA DI resources for healthcare providers and the increasing application of physiologically based pharmacokinetic modeling (PBPK) to identify potential drug interactions during drug development will also be discussed.
Objectives:
  • Identify three key elements that must be included in the Drug Interactions section of the prescribing information (PI)
  • Distinguish between the type of information that should be included in the Drug Interactions and Clinical Pharmacology sections of the PI
  • Locate examples of drugs that interact with Cytochrome P450 (CYP) enzymes and transporter systems by searching the FDA resource https://www.fda.gov/CYPandTransporterInteractingDrugs
  • Describe the utility of physiologically based pharmacokinetic modeling (PBPK) modeling for identifying potential drug interactions in drug development
Additional Information: Review the Activity Announcement for additional details: Announcement Form