Author: [AUTHOR] Published on 5/19/2023 6:00:00 AM

FDA Announces a Public Webinar on Clinical Pharmacology Considerations for Food Effect Studies

On June 15, 2023, the US Food and Drug Administration’s (FDA’s) Small Business and Industry Assistance (SBIA) will hold a one-hour webinar entitled "Overview: Clinical Pharmacology Considerations for Food Effect Studies." The purpose of this webinar is to discuss the importance of assessing the effect of food on drugs and reasons for issuing the final guidance, timing of conducting food effect studies during drug development, general considerations for designing food effect studies, and other considerations related to assessing the effect of food on a drug, including the types of meals to evaluate.

Learning Objectives:

• Understand the importance of assessing the effect of food on drugs
• Comprehend general considerations for designing food effect studies
• Discuss data analysis considerations related to food effect assessment

Date/Time of the Webinar:
Date: June 15, 2023
Time: 1:00 p.m. – 2:00 p.m. ET

This webinar is intended for drug development scientists involved with food effect studies conducted to support regulatory submissions, scientists assessing food effect studies submitted as part of regulatory submissions, and foreign regulators and policy makers. This webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. Please see the detailed announcement for more information.

This virtual webinar is open to the public; however, registration is required at the SBIA registration website. More information about this event can be found at the Clinical Pharmacology Considerations for Food Effect Studies webinar website.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.