FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update
February 28, 2022 - December 31, 2024
This webinar discussed how the Office of Orphan Products Development (OOPD) advances the development of products for rare diseases. The webinar also reviewed the history of OOPD, the Orphan Drug Act, and other core programs within OOPD.
- Developing Products for Rare Diseases & Conditions: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm.
- Designating an Orphan Product: Drugs and Biological Products: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/designating-orphan-product-drugs-and-biological-products.
- Rare Pediatric Disease Designation Program: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm.
- Humanitarian Use Device (HUD) Designation program: https://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/DesignatingHumanitarianUseDevicesHUDS/default.htm.
- About Orphan Products Grants: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/about-orphan-products-grants.
- Pediatric Device Consortia Grants Program: https://www.fda.gov/industry/developing-products-rare-diseases-conditions/pediatric-device-consortia-grants-program.
- Describe the mission of Office of Orphan Products Development (OOPD).
- Define rare disease in accordance with the Orphan Drug Act.
- Identify the incentives associated with orphan drug designation.
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health Professionals (CPH), and physician assistants.
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.
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.
Faculty
- Rubio, Teresa, PharmD, Health science administrator, FDA - nothing to disclose
- Wolanski, Nicole, Deputy Director, Office of Orphan Products Development, 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
All relevant financial relationships have been mitigated.
Registration is complimentary; therefore refunds are not applicable.
Must attend 100% of the activity.
Initial Release Date
February 28, 2022
Expiration Date
December 31, 2024