OFFICIAL-SOURCE RECALL · UNITED STATES
Join SBIA for Two Upcoming FDA Webinars on U.S. Prescribing Recall: Receive this email as a forward?
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Receive this email as a forward? Subscribe to CDER SBIA industry updates. CDER | Small Business and Industry Assistance (SBIA) Communicating Drug Interaction and QTc Information in the U.S. Prescribing Information September 23, 2026 | 1:00 p.m. - 3:00 p.m. ET These webinars are designed for pharmaceutical industry members who develop labeling for prescription drugs regulated under NDAs or biological products regulated under BLAs. They are also relevant for clinical pharmacology, QTc interval and drug interaction experts, safety specialists, and professionals working on drug and safety communication. 🔎 Learn More and Register Webinar 1: Drug Interaction Information in the U.S. Prescribing Information This webinar will discuss the following topics in the draft guidance for industry, Drug Interaction Information in Human Prescription Drug and Biological Product Labeling (October 2024), to include: Section organization and format, including required and recommended elements Instructions for preventing or managing, and mechanisms and clinical effects of clinically significant drug interactions Information on other sections of labeling, including BOXED WARNING, DOSAGE AND ADMINISTRATION, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY sections Read the Draft Guidance Webinar 2: QTc Interval Information in the U.S. Prescribing Information This webinar will discuss the following topics in the draft guidance for industry, QTc Information in Human Prescription Drug and Biological Product Labeling (December 2025), to include: Risk factors for and clinical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no clinically significant QTc interval prolongation, or insufficient data to characterize the risk Read the Draft Guidance The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. Register for Upcoming Training View the SBIA 2026 YouTube Playlist View the SBIA 2025 YouTube Playlist Subscribe to CDER SBIA Email Updates Connect on LinkedIn Follow on X This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707. SUBSCRIBER SERVICES: Manage Subscriptions | Unsubscribe All | Help
Official recall notice
Join SBIA for Two Upcoming FDA Webinars on U.S. Prescribing Information: QTc Interval and Drug Interaction Information
Agency: FDA MedWatch
Official publication date: August 10, 2026
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