FDA Drug Topics: FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update
April 26, 2021
FDA's Division of Drug Information in the Center for Drug Evaluation and Research (CDER) sponsors a series of educational webinars targeting the needs of health care professionals and students. The webinars cover a broad range of FDA drug regulation and medication safety topics. These focused webinars support FDA's mission of promoting and protecting public health through interaction and education to strengthen current and future partnerships and relationships with clinicians and researchers.
This webinar will discuss how the Office of Orphan Products Development (OOPD) advances the development of products for rare diseases. The webinar will also review 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
- Explain how to utilize FDA's Drug Information, medication safety resources, and regulatory guidances to improve delivery of patient care and optimize outcomes.
- Describe and inform health care providers of recent labeling, policy and regulatory changes which would impact prescribing and medication management to optimize patient care.
- 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 (CPH), and physician assistants.
Lecture 1 April 26, 2021
|1:00 - 2:00 PM||FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update||
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.
- Rubio, Teresa, Health science administrator, FDA nothing to disclose
- Wolanski, Nicole, Deputy Director, Office of Orphan Products Development, FDA nothing to disclose
- Burke, Kara, PharmD, Team Leader/Pharmacist, FDA/CDER/OCOMM/DDI nothing to disclose
- Cao, Christian, MPAS, PA-C, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV nothing to disclose
- DeFronzo, Kimberly, RPh, MS, MBA, Consumer Safety Officer, FDA/CDER/OCOMM/DDI nothing to disclose
- Kapoor, Rama, MD, Medical Officer, FDA nothing to disclose
- Navin, Lesley, RN, MSN, Consumer Safety Officer, FDA/CDER/DDI nothing to disclose
- Nguyen-Chu, Thanh Tam, PharmD, Pharmacist, FDA/CDER/OCOMM/DDI nothing to disclose
- Paraoan, Dianne, MPH, RN, Associate Director for Regulatory Affairs, FDA/ CDER/ OMP nothing to disclose
CE Consultation and Accreditation Team
- Bryant, Traci, M.A.T., CE Consultant, FDA/CDER/OEP/DLOD - nothing to disclose
- Zawalick, Karen, CE Team Leader, FDA/CDER/OEP/DLOD - nothing to disclose
Registration is complimentary, therefore refunds are not applicable.
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