Webcast | Virtual
Event Title
Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information
September 23, 2026
- Date:
- September 23, 2026
- Time:
- 1:00 p.m. - 3:00 p.m. ET
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About this Event (Hosted by CDER SBIA)
The first session of this webinar will discuss the draft guidance for industry: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024).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.
Intended Audience
Pharmaceutical industry members who:
- Work on developing labeling for prescription drugs, including “branded” drugs (regulated under NDAs) and biological products (regulated under BLAs). Especially those that develop QTc interval information in the U.S. Prescribing Information.
- Are clinical pharmacology, cardiology, or QTc interval experts
- Sponsor drugs with QTc interval prolongation or sponsor drugs that have low risk of QTc interval prolongation
- Are safety specialists
- Work on drug communication of drug risks, and regarding QTc interval prolongation information
Presentations
Drug Interaction Information in the U.S. Prescribing Information
Speaker: Eric Brodsky, MD
Director, Labeling Policy Team
Office of New Drugs (OND) | CDER | FDA
QTc Interval Information in the U.S. Prescribing Information
Speaker: Christine Garnett, PharmD
Associate Director
Division of Cardiology and Nephrology
Office of Cardiology, Hematology, Endocrinology, and Nephrology
OND | CDER | FDA
Panelists:
Eric Brodsky, MD, Christine Garnett, PharmD
and
Kellie Schoolar Reynolds, PharmD
Acting Deputy Director
Office of Clinical Pharmacology
Office of Translational Sciences | CDER | FDA
Resources
- Guidance for industry: QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025).
- Draft guidance for industry: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024); when final this guidance, will represent the FDA’s current thinking on this topic.
- Draft guidance for industry, Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (January 2023); when final this guidance, will represent the FDA’s current thinking on this topic.
- Guidance for industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products – Content and Format (October 2011)
- Prescribing Information Resources
- Understanding FDA’s prescription drug labeling resources