www.hhs.gov U.S. Department of Health and Human Services
Activity Outline
FDA Drug Topics: FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update
April 26, 2021
FDA
Activity Coordinator:
Lesley Navin (Lesley.Navin@fda.hhs.gov),  Kara Burke (Kara.Burke@fda.hhs.gov),  Kimberly DeFronzo (Kimberly.Defronzo@fda.hhs.gov),  Thanh Tam Nguyen-Chu (thanh.nguyen-chu@fda.hhs.gov)
 
Series Description

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.


Lecture Description
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.
References
  • 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
Series Objectives
  • 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.
Learning Objectives After completion of this activity, the participant will be able to:
  • 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.
Target Audience
This activity is intended for physicians, pharmacists, pharmacy technicians, nurses, Certified Public Health (CPH), and physician assistants.
Agenda

Lecture 1 April 26, 2021
Time Topic Speaker
1:00 - 2:00 PM FDA’s Office of Orphan Products Development (OOPD) – An Overview and Update Teresa Rubio
Nicole Wolanski
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 live activity 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 JA0002895-0000-21-037-L04-P, and ACPE Universal Activity Number JA0002895-0000-21-037-L04-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. 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
  • Rubio, Teresa, 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, Safety Evaluator Team Leader, FDA/CDER/OSE/DPV 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
  • 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 Fee and Refunds
Registration is complimentary, therefore refunds are not applicable.
ACCME Joint Accreditation
  • This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing this Government system, which includes (1) this computer network, (2) all computers connected to this network, and (3) all devices and storage media attached to this network or to a computer on this network.
  • This system is provided for Government-authorized use only.
  • Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties.
  • Personal use of social media and networking sites on this system is limited as to not interfere with official work duties and is subject to monitoring.
  • By using this system, you understand and consent to the following:
    • The Government may monitor, record, and audit your system usage, including usage of personal devices and email systems for official duties or to conduct HHS business. Therefore, you have no reasonable expectation of privacy regarding any communication or data transiting or stored on this system. At any time, and for any lawful Government purpose, the government may monitor, intercept, and search and seize any communication or data transiting or stored on this system.
    • Any communication or data transiting or stored on this system may be disclosed or used for any lawful Government purpose.