On June 15, 2023 from 1pm to 2pm ET, the FDA will host the following webinar: Clinical Pharmacology Considerations for Food Effect studies.

The webinar will cover the following topics:

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

The Learning Objectives include:

  • 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

Hosted by FDA speakers and 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

If you’d like to attend this free webinar, register here. Of note, this webinar has been approved for 1.00 contact hour of continuing education for physicians, pharmacists, and nurses. 

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
  • No official support by any organization(s) has been provided or should be inferred