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  1. Non-Profit and Other MOUs

MOU 225-25-006

MEMORANDUM OF UNDERSTANDING BETWEEN THE AMERICAN SOCIETY OF PEDIATRIC HEMATOLOGY/ONCOLOGY AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG ADMINISTRATION, ONCOLOGY CENTER OF EXCELLENCE

PURPOSE

The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) and the American Society of Pediatric Hematology/Oncology (ASPHO) agree to establish the FDA-ASPHO Pediatric Hematology/Oncology Educational Program. The FDA and ASPHO share interests in promoting scientific progress through exchange of scientific knowledge in pediatric hematology/oncology education, collaborative learning, and research. Both institutions foresee benefits from the mutual exchange of educational expertise in translational pediatric hematology/oncology drug development and regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for this Educational Program and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning.

BACKGROUND

The FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, the FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, biologics, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics.  The FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, the FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education, and outreach partnerships within ASPHO will greatly contribute to the FDA’s mission.    

The mission of the OCE is to achieve patient-centered regulatory decision-making through innovation and collaboration. The OCE’s vision is to create a unified and collaborative scientific environment to advance the development and regulation of oncology products for patients with cancer. The OCE leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The OCE helps expedite development of medical products for solid tumors and hematologic malignancies and supports an integrated approach to their clinical evaluation. Proactive scientific education and collaboration with ASPHO is consistent with the OCE’s vision and mission.  

The mission of the American Society of Pediatric Hematology/Oncology is to support and empower the pediatric hematology and oncology medical and scientific community with a vision for improved health and a better future for children, adolescents, and young adults with cancer and blood disorders. ASPHO provides a forum for the exchange of ideas on issues of special interests and concern to people in the specialty, as well as a means for facilitating communication among members. Its goals are to strengthen the impact on pediatric hematology/oncology care through advocacy and partnerships, to promote research and innovation to enhance understanding of disease processes and improve patient outcomes and care delivery, to provide a comprehensive portfolio to address the diverse educational needs of learners, to deliver opportunities for career development and community engagement, and to assess and communicate trends and innovations in the workforce and practice models.

The FDA and ASPHO intend to leverage their combined strengths for the joint development of the Educational Program, to educate and provide career development for the selected participants through collaborative learning and other training experiences, thereby fostering a greater understanding of pediatric hematology/oncology drug development and regulatory policy.

The OCE and ASPHO have complementary missions and rely on the expertise of pediatric hematologists/oncologists and scientists that are well-trained in the fundamentals of drug and diagnostic development and approval. Such individuals work in every sector, from academia to industry to government to clinical practice. This Educational Program and other joint efforts will help to fill an existing critical gap in pediatric hematology/oncology training, providing candidates education relating to, among other things, regulatory science, and the pediatric hematology/oncology drug approval process.

SUBSTANCE OF AGREEMENT

This MOU is the foundation for the development of the FDA-ASPHO Pediatric Hematology/Oncology Educational Program. The objective of these efforts is to educate pediatric hematology/oncology fellows and young investigators about pediatric hematology/oncology drug development and regulatory policy. Educational topics may include:

  • Pediatric hematology/oncology drug regulation
  • The Investigational New Drug (IND) process
  • The New Drug Application (NDA) and Biologic License Application (BLA) process
  • Expedited drug development pathways
  • Pharmacology and toxicology considerations in early phase clinical trials
  • Clinical pharmacology considerations throughout pediatric hematology/oncology drug development including dosage optimization
  • Statistical considerations in late phase clinical trials
  • Clinical trial design and efficacy endpoint considerations
  • Companion diagnostics, biomarkers, and precision oncology
  • Pediatric hematology/oncology disease area subject matters (clinical practice, biomarker development, etc.)

The following individuals may apply for this educational program: current pediatric hematology/oncology fellows and early-career pediatric hematology/oncology faculty. Current pediatric hematology/oncology fellows must have completed at least two years of fellowship training in an accredited U.S. training program and be in good standing in their fellowship programs. Early-career faculty must be within 10 years of starting their faculty appointment.  Applicants must also be ASPHO members in good standing.

The FDA and ASPHO will jointly review the applications and select approximately 20 participants per year, with a 1-year Educational Program duration, unless extended by joint agreement of the OCE and ASPHO. The Educational Program pilot will be for 1 year and can be extended for up to 5 years total by joint agreement of the OCE and ASPHO. 

Roles and Responsibilities of the Parties

ASPHO will be responsible for:

  • Advertisement and promotion of the Educational Program
  • Coordinating the Educational Program application process
  • Providing input on Educational Program applicants
  • Jointly with the OCE, deciding on the acceptance of applicants
  • Notification of accepted and not accepted participants
  • Providing input on the Educational Program structure and content
  • Hosting a one-day in-person meeting in conjunction with the ASPHO conference

The FDA will be responsible for:

  • Providing input on Educational Program applicants
  • Jointly with ASPHO, deciding on the acceptance of applicants
  • Providing educational materials and teaching to selected participants on regulatory policy and pediatric hematology/oncology drug development, using only publicly available documents and materials. These teaching sessions will be primarily virtual.

At this stage, OCE and ASPHO contemplate having participants who will not be regularly resident at FDA for the term of their educational program.  If, at a later time, OCE and ASPHO decide to pursue in-person participants resident at FDA, they will execute an appropriate addendum to the MOU, or a separate MOU, covering such participants.

The sharing of non-public information is not permitted under the terms of this MOU, including FDA non-public information, confidential commercial and/or trade secret information in FDA’s possession, and/or ASPHO non-public information, OCE staff participating in this Educational Program, or in other joint educational efforts with ASPHO, including interacting with participants, shall not further release, publish, or disclose FDA non-public information, and/or or confidential commercial or trade secret information, and they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of privileged information.

PROMOTIONAL ACTIVITY

The ASPHO will not use the Educational Program as a vehicle to sell or promote commercial products or commercial services.

EDUCATIONAL PROGRAM PUBLICITY AND ENDORSEMENT

The ASPHO agrees not to use the name of the FDA or any of the FDA components, except in factual publicity for the Educational Program. Such factual publicity shall not imply that the involvement of the FDA serves as an endorsement of the general policies, activities, or products of ASPHO. Where confusion could result, publicity should be accompanied by a disclaimer to the effect that no endorsement is intended. ASPHO will clear all publicity materials with the FDA to ensure compliance with this paragraph.

TERMINATION

Non-adherence to the terms of this agreement may result in the FDA terminating the agreement.

RESOURCE OBLIGATIONS

This MOU represents the broad outline of the FDA and ASPHO’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not create binding, enforceable obligations against either Party. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. Separate additional educational activities may be planned (e.g., workshop, lectures, etc.). 

Liaison Officers

For ASPHO:

Sally Weir
American Society of Pediatric Hematology/Oncology
1061 American Lane, Ste 310
Schaumburg, IL 60173
sweir@aspho.org

For the FDA/OCE:

Martha Donoghue
Oncology Center of Excellence  
Building 22, Room 2314
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 
Martha.donoghue@fda.hhs.gov

Each Party may designate new liaisons at any time by notifying the other Party's administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.  

Terms, Termination and Modification

This agreement, when accepted by all partners, will have an effective period of performance of five years, from the date of the latest signature.  It may be modified or terminated by mutual written consent of the Partners or may be terminated by either Partner(s) upon a 14-day advance written notice to the other.

APPROVED AND ACCEPTED BY THE U.S. FOOD AND DRUG ADMINISTRATION:

/s/
Richard Pazdur, M.D. 
Director, Oncology Center of Excellence
U.S. Food and Drug Administration
Date: 07/10/2025

APPROVED AND ACCEPTED BY THE AMERICAN SOCIETY OF PEDIATRIC HEMATOLOGY/ONCOLOGY:

/s/
Sally Weir, CAE
Executive Director/CEO
American Society of Pediatric Hematology/Oncology
Date: 07/08/2025

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