FDA Webinar: Overview: Clinical Pharmacology Considerations for Food Effect Studies

For those who participate in or support food effect studies a good opportunity to hear FDA perspectives on the guidance

Date:  June 15, 2023

Time:1:00 PM - 2:00 PM ET

Registration link 

In this webinar, FDA will discuss:

• 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
• Other considerations related to assessing the effect of food on a drug

TOPICS COVERED

• Timing of conducting food effect studies during drug development
• Type of meals to be evaluated
• General considerations for designing food effect studies

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

FDA SPEAKERS

Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review, Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA

Panelists

Vikram Arya, Ph.D., FCP
Associate Director for Therapeutic Review, Division of Infectious Disease Pharmacology | Office of Clinical Pharmacology| CDER | FDA

Brian Booth, Ph.D.
Director; Division of Cancer Pharmacology I | Office of Clinical Pharmacology | CDER | FDA

Ethan Stier, Ph.D.
Associate Director for Lifecycle Management, Immediate Office | Office of Clinical Pharmacology | CDER | FDA