Important Orange Book Facts
September 18, 2024 - September 17, 2027
YouTube
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.
- 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
- 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.
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
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.
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.
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
All relevant financial relationships have been mitigated.
Must attend 100% of the activity.
Initial Release Date
September 18, 2024
Expiration Date
September 17, 2027