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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research
Activity Outline
Project Facilitate: Oncology Expanded Access Program Update
February 28, 2022 - December 31, 2023


Activity Coordinators:
Thanh Nguyen-Chu (Thanh.Nguyen-Chu@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly De Fronzo (Kimberly.Defronzo@fda.hhs.gov)
Description

This webinar will discuss Expanded Access, the regulatory pathway by which an oncologist may obtain access to an investigational drug product for the purposes of treating a patient with a life-threatening medical condition for which there is no acceptable treatment. The FDA Oncology Center of Excellence's Project Facilitate was established to meet the demand for oncology Expanded Access through increasing awareness of this pathway, increasing accessibility and establishing a single point-of-contact for the public. Project Facilitate is continually improving oncology Expanded Access to ensure everyone has personalized support when submitting their application.

References
  • Lemery, S., Mailankody, S., Kazandjian, D., Demiette Smit, M., Blumenthal, G., Kim, T., Keegan, P., McKee, A., Pazdur, R. (2016, June). Food and Drug Administration analysis of 1332 single patient and emergency use expanded access (compassionate use) requests for patients with cancer over a duration of three years (2012-2014). Abstract accepted and poster presented as American Society of Clinical Oncology Annual Meeting, Chicago, IL.
  • Project facilitate: A review of the FDA oncology center of excellence expanded access pilot program. Natasha L Kormanik, Mitchell Chan, Jessica Boehmer, Tamy Kim, Gideon Michael Blumenthal, and Richard Pazdur. Journal of Clinical Oncology 2020 38:15_suppl, 7023-7023
  • Reagan-Udall Foundation (n.d.). Expanded Access Navigator. Retrieved from https://reaganudall.org/
Learning Objectives
  • Define expanded access and the key requirements for an expanded access request for an individual patient.
  • Summarize the key responsibilities of the oncology healthcare professional when considering expanded access for a patient.
  • Identify resources available to healthcare professionals considering submission of an oncology expanded access request for an individual patient.
  • Describe how Project Facilitate is a resource to navigate the oncology Expanded Access pathway.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH) Professionals, and physician assistants.
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.
CME
FDA Center for Drug Evaluation and Research designates this enduring material 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.
CPE
This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-22-025-H04-P , and ACPE Universal Activity Number JA0002895-0000-22-025-H04-T for 1.00 contact hour(s).
CNE
FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).
AAPA
This activity is designated for 1.00 AAPA Category 1 CME credits. FDA Center for Drug Evaluation and Research has been authorized by the American Academy of PAs (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria.Approval is valid until December 31, 2023. PAs should only claim credit commensurate with the extent of their participation.
CPH
Up to 1.00 CPH Recertification Credits may be earned at this event.
Requirements for Receiving CE Credit

Physicians, physician assistants, pharmacists, nurses, pharmacist techs, 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, physician assistants, 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.
Disclosure

Faculty
  • Chan, Mitchell, PharmD, BCPS, Clinical Analyst, FDA - 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
  • Zawalick, Karen, CE Team Leader, 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 Information
Registration is complimentary; therefore refunds are not applicable.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
April 30, 2021

Revised Date
February 28, 2022

Expiration Date
December 31, 2023