Communicating Drug Interaction and QTc Information
in the U.S. Prescribing Information
September 23, 2026
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The first session of this webinar will discuss the draft guidance for industry: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024). Topics include:
- DRUG INTERACTIONS section:
- Organization and format
- Required and recommended elements
- Instructions for preventing or managing clinically significant drug interactions
- Mechanisms of clinically significant drug interactions
- Clinical effects of clinically significant drug interactions
- Recommendations on including drug interacting class information
- Information to avoid in the DRUG INTERACTIONS section
- Drug interactions information in other sections of labeling (e.g., BOXED WARNING, DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY sections)
The second session of this webinar will discuss the guidance for industry:QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025). Topics include:
- Risk factors for and clinical consequences of QTc interval prolongation
- Assessment of the QTc interval during drug development
- Including QTc interval information in the CLINICAL PHARMACOLOGY section when there is:
- Clinically significant QTc interval prolongation
- No clinically significant QTc interval prolongation
- Insufficient data to characterize the risk
- Including QTc interval information in the DRUG INTERACTIONS section when the use of the subject drug with other products:
- That are known or suspected to prolong the QTc interval
- Increase the concentration of the subject drug (when there is a concentration-dependent QTc interval prolongation.
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Continuing Education
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