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

This virtual event is FREE!

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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The first session of this webinar will discuss the draft guidance for industry: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024).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

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

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