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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
Important Orange Book Facts
September 18, 2024 - September 17, 2027
YouTube

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

The purpose of this webinar is to discuss commonly asked questions from the Orange Book Questions and Answers Guidance for Industry. Topics will include Orange Book content and format and how to use the Orange Book to find information on therapeutic equivalence, marketing status, patents and exclusivities.

References
  • Orange Book Questions and Answers Guidance for Industry (July 2022): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/orange-book-questions-and-answers-guidance-industry
  • Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act; Content and Format (August 2020): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-status-notifications-under-section-506i-federal-food-drug-and-cosmetic-act
  • Orange Book Preface: https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface
  • Orange Book website: https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
Learning Objectives
  • Discuss the inclusion of products in the Orange Book.
  • Utilize the Orange Book to identify therapeutically equivalent products.
  • Recognize the statutory requirements for the movement of drug products between the active and discontinued sections of the Orange Book.
  • Identify the requirements for listing and removing patent information.
  • Distinguish the different types of exclusivities listed in the Orange Book.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.
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 JA0002895-0000-24-096-H99-P, and ACPE Universal Activity Number JA0002895-0000-24-096-H99-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
FDA Center for Drug Evaluation and Research has been authorized by the American Academy of Physician Associates (AAPA) to award AAPA Category 1 CME credit for activities planned in accordance with AAPA CME Criteria. This activity is designated for 1.00 AAPA Category 1 CME credits. Approval is valid until September 17, 2027. 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

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor®. If you do not see your credit reflected on CPE Monitor®* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov.
*CPE Monitor® sets a strict 60-day limit on uploading credits.

Disclosure

Faculty
  • Chan, Eva, PharmD, Pharmacist, Food and Drug Administration - nothing to disclose
  • Quach, Truong, PharmD, Pharmacist, 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
  • Faberlle, Alexandra M., 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.
Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
September 18, 2024

Expiration Date
September 17, 2027