www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
CDER Small Business and Industry Assistance 1 Hour Web Series: Overview: Clinical Pharmacology Considerations for Food Effect Studies
June 15, 2023

Activity Coordinators:
Forest Ford (forest.ford@fda.hhs.gov),  Brenda Stodart (brenda.stodart@fda.hhs.gov)
Series Description

FDA's CDER Small Business and Industry Assistance (SBIA) educational webinars target the needs of health care professionals working in the pharmaceutical industry. Subject matter experts from the FDA explain trending drug development topics, (e.g. labeling, adverse events, quality) new guidance's or regulations, and/or FDA regulatory processes. These webinars support FDA's mission of promoting and protecting public health by bridging knowledge gaps about emerging regulatory issues or areas with frequently asked questions.

Lecture Description
In this webinar, FDA will discuss the importance of assessing the food effect studies on drugs and reasons for issuing the final guidance. The timing of conducting food effect studies during drug development, and the type of meals being evaluated will be reviewed. In addition, the presentation will also focus on the design of food effect studies, and examine other factors related to assessing the effect of food on a drug.
  • Final Food Effect Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-effects-food-drugs-inds-and-ndas-clinical-pharmacology-considerations
Series Objectives
  • Demonstrate the ability to solve FDA drug regulatory issues as they arise.
  • Explain new FDA regulatory initiatives.
Learning Objectives After completion of this activity, the participant will be able to:
  • Describe the importance of assessing the effect of food on drugs
  • Explain general considerations for designing food effect studies
  • Discuss data analysis considerations related to food effect assessment
Target Audience
This activity is intended for physicians, pharmacists, and nurses.

Lecture 1 June 15, 2023
Time Topic Speaker
1:00 - 2:00 PM EDT Overview: Clinical Pharmacology Considerations for Food Effect Studies Brenda Stodart, PharmD, MS, BCGP, RAC
Forest Ford, PharmD, R. Ph
Brian Booth, PhD
Ethan Stier
Continuing Education Accreditation
Jointly Accredited Provider
In support of improving patient care, FDA Center for Drug Evaluation and Research is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.
ICPE Credit
This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.
FDA Center for Drug Evaluation and Research designates this live activity for a maximum of 1.00 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity.
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-23-008-L99-P for 1.00 contact hour(s).
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
Requirements for Receiving CE Credit

Physicians, pharmacists, nurses, and those claiming non-physician CME: participants must attest to their attendance and complete the final activity evaluation via the CE Portal (ceportal.fda.gov). For multi-day activities, participants must attest to their attendance and complete the faculty evaluation each day. Final activity evaluations must be completed within two weeks after the activity - no exceptions.

Attention Pharmacists and Pharmacy Techs: Failure to provide your correct NABP AND Date of Birth information, in the required format, may result in the loss of credit for this activity. NABP profile number should be the 6-7 digit profile number assigned by the CPE Monitor and your birth date should be in the MMDD format (e.g. 0721) Do not provide your pharmacy license number. Please click the "My Account" tab and then navigate to "Edit Contact Information" to verify that your information is correct.

Important Note regarding completion of evaluations and receiving credit
Attendees have 14 days from the last day of the activity to log in, complete the required evaluation(s) and attest to your attendance to claim credit.Physicians and nurses may then view/print statement of credit. Pharmacists should log into the CPE monitor 8 weeks after the last session of the activity to obtain their CE credit.

  • ARYA, VIKRAM, PhD, Associate Director for Therapeutic Review, Food and Drug Administration - nothing to disclose
  • Booth, Brian, PhD, Director, CDER\OTS\OCP\DCP I - nothing to disclose
  • Ford, Forest, PharmD, R. Ph, CSO, FDA - nothing to disclose
  • Stier, Ethan, Associate Director, FDA - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

Planning Committee
  • Brodsky, Eric, MD, Associate Director, FDA/CDER/OND/Labeling Policy Team - nothing to disclose
  • Paraoan, Dianne, MPH, BSN, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP - nothing to disclose
  • Stodart, Brenda, PharmD, MS, BCGP, RAC, Program Director, FDA - nothing to disclose

CE Consultation and Accreditation Team
  • Darlise Henderson, MBA, 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
Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.
Registration Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
  • This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
  • This system is provided for Government-authorized use only.
  • Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
  • Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
  • By using this system, you understand and consent to the following:
    • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
    • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.