Series Description

FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.

Lecture 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.

References

• Grillo, J. & Tran, M. Translation of drug interaction knowledge to actionable labeling. Clin. Pharmacol. Ther. 105, 1292– 1295 (2019).
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Labeling for Human Prescription Drug and Biological Products - Implementing the PLR Content and Format Requirements: Guidance for Industry. February 2013. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/labeling-human-prescription-drug-and-biological-products-implementing-plr-content-and-format. Accessed January 19, 2024.
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format: Guidance for Industry. December 2016. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-labeling-human-prescription-drug-and-biological-products-content-and-format. Accessed January 19, 2024.
• Grillo JA, Zhao P, Bullock J, et al. Utility of a physiologically-based pharmacokinetic (PBPK) modeling approach to quantitatively predict a complex drug-drug-disease interaction scenario for rivaroxaban during the drug review process: implications for clinical practice. Biopharm Drug Dispos. 2012;33(2):99-110.
• Zhang X, Yang Y, Grimstein M, et al. Application of PBPK Modeling and Simulation for Regulatory Decision Making and Its Impact on US Prescribing Information: An Update on the 2018-2019 Submissions to the US FDA's Office of Clinical Pharmacology. J Clin Pharmacol. 2020;60 Suppl 1:S160-S178.

Series Objectives

• Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
• Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.

Learning Objectives After completion of this activity, the participant will be able to:

• 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 (PBPK) modeling for identifying potential drug interactions in drug development

Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

• Grillo, Joseph, PharmD, Associate Director for Labeling and Health Communication, FDA/CDER/OTS/OCP - nothing to disclose

Planning Committee

• Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Cao, Christian, MPAS, PA-C, Cross-Discipline Safety Advisor, FDA/CDER/OSE/OPE - nothing to disclose
• De Fronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI - nothing to disclose
• Kapoor, Rama, MD, Senior Physician, FDA - nothing to disclose
• Nguyen-Chu, Thanh, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI - nothing to disclose
• Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose

CE Consultation and Accreditation Team

• Littlefield, Jr, Kenneth P., Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose