Non-Profit and Other MOUs
| MOU No. | Purpose | Parties | FDA Lead Center or Office Contact | Effective Date | Expiration Date | Last Revision Date |
|---|---|---|---|---|---|---|
| 225-24-020 | This MOU is intended to clarify roles, responsibilities, and collaborative communications primarily related to the FDA-USP Government Liaison Program. | United States Pharmacopeia and FDA | Pallavi Nithyanandan Office of Pharmaceutical Quality | 2024-09-03 | Indefinite | |
| 225-24-009 | Established for communication, sharing information, and developing strategies to address cybersecurity threats to medical devices and the software supply chain. | Medical Device Information Sharing and Analysis Organization (MedISAO) | CDRH And CDRH | 2024-04-18 | 2029-04-18 | |
| 225-24-012 | FDA CTP and Truth Initiative® will collaborate on a data harmonization project using outcome evaluation data. The purpose of this project is to increase understanding of the impact of the combined effect of tobacco use prevention campaigns on psychosocial and behavioral outcomes. | Truth Initiative | OHCE Katie Case Social Scientist- Project Lead Kathleen.case@fda.hhs.gov | 2024-06-11 | 2029-06-11 | |
| 225-24-008 | Share cybersecurity risks, vulnerability and threat information on medical devices, and develop innovative strategies to identify, mitigate and prevent threats. | CloudWave-ISAO | CDRH Jessica Wilkerson, J.D. | 2024-03-25 | 2029-03-25 | |
225-24-002 | To promote awareness and develop strategies to identify, mitigate, and prevent cybersecurity threats to medical devices. | Health Information Sharing & Analysis Center, Inc. (Health-ISAC) | CDRH CDRH | 2023-12-14 | 2028-12-14 | |
| 225-22-018 | Share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine. | Society of Toxicology | Office of the Chief Scientist Chad P. Nelson, Ph.D., M.S.P.H 301-796-4643 | 2022-07-29 | 2027-07-29 | |
| 225-20-015 | The Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), the American Association for Cancer Research (AACR), Oncology Nursing Society (ONS) and Hematology/Oncology Pharmacy Association (HOPA) agree to collaborate in Project Livin’ Label, a new educational initiative aimed at increasing awareness of recent FDA oncology drug approvals and understanding of the associated drug product label. The FDA, AACR, ONS and HOPA share interests in promoting scientific progress through exchange of scientific capital in oncology education, collaborative learning, and research. All institutions foresee benefits from collaborating in this new educational initiative focused on regulatory policy. This Memorandum of Understanding (MOU) establishes the terms for the collaboration for Project Livin’ Label and provides a basis for other related efforts to promote these shared, mutual interests in collaborative education and learning. | American Association for Cancer Research (AACR), Oncology Nursing Society (ONS) and Hematology/Oncology Pharmacy Association (HOPA) | Oncology Center of Excellence Laura B. Wisch Program Manager for Education 10903 New Hampshire Ave, WO 22/2135 Silver Spring, MD 20993 Laura.wisch@fda.hhs.gov 301-538-6580 | 2022-05-03 | 2027-05-03 | |
| 225–20–018 | FDA and the Academy will collaborate to increase the awareness of agricultural biotechnology/genetically engineered foods and develop educational materials for dietitians. | Academy of Nutrition and Dietetics | CFSAN Sharmi Das Phone: (240) 402-3786 | 2020-09-04 | Lifespan of the CPE Learning Series (a maximum of 3 years) | |
| 225-78-1000 | States the responsibilities of the FDA and NCIMS for execution of the Interstate Milk Shippers Program, the means for resolving questions of interpretation that may arise in the execution of the Program, and the means for making modifications in the Program. | National Conference on Interstate Milk Shipments | CFSAN Monica Metz (240) 402-2041 | 1977-09-12 | Indefinite | |
| 225-83-3000 | Defines the working arrangements between FDA and USPC in regards to the review revisions to compendial requirements for drugs. | U.S. Pharmacopeial Convention, Inc. (USPC) | CDER Diane Ehrlich (301) 443-5373 | 1983-09-07 | Indefinite | |
| 225-84-2003 | To foster and improve the sanitation and quality of shellfish in the U.S. | Interstate Shellfish Sanitation Conference (ISSC) | CFSAN Donald Kraemer (240) 402-2300 | 1984-03-14 | Indefinite | |
| 225-93-4006 | CFP and FDA agree to establish a working relationship to address issues on food safety in order to implement the recommendations adopted at Conference meetings. | Conference for Food Protection (CFP) | ORA Diana Kolaitis (718) 662-5416 | 1993-08-01 | Indefinite | |
| 225-93-7000 | Evaluating test kits for detecting animal drug residues in milk. | AOAC | CVM Tracey Forfa (240) 276-9006 | 1992-10-22 | Indefinite | |
| 225-03-4000B | FDA and NTEU agree to work together regarding mandatory foreign inspection assignments. | National Treasury Employees Union (NTEU) | ORA Diana Kolaitis (718) 662-5416 | 2003-06-11 | expires w/contract | |
| 225-04-4002 | FDA and BIG will work together to address issues affecting children, families, and communities within each organizations jurisdiction through educational campaigns-food safety. | Blacks in Government (BIG) | OC LaJuana Caldwell (301) 827-4450 | 2003-10-22 | Indefinite | |
| 225-10-0021 | Defines the framework in which the FDA will provide publicly available content to be used in health professional informational, educational, and training programs that will be run by WebMD LLC ("WebMD") and Medscape, LLC ("Medscape"), an entity accredited by ACCME, ANCC, and the ACPT to provide continuing professional education to physicians, nurses and pharmacists, respectively. Amended to extend expiration date. | Medscape, LLC and WebMD | OC/OEA Anna Fine (301) 796-8471 | 2014-06-07 | 2019-06-06 | |
| 225-11-0021 | Establishes a strategic framework for collaboration between FDA and the Uppsala Monitoring Centre (UMC) in Sweden and outlines the process for collaborative sharing of public information between the FDA and the UMC for carrying out their common goal to improve the global safety and effective use of medicinal products. | Uppsala Monitoring Centre (Sweden) | CDER Gerald Dal Pan (301) 796-2380 | 2012-05-15 | Indefinite | |
| 225-12-0001 | The purpose of MOU 225-12-0001 is to promote initiatives related to radiation protection from CT medical imaging. | Heads of the European Radiological protection Competent Authorities (HERCA) | CDRH | 2012-02-02 | Indefinite | |
| 225-12-0038 | Establishes the terms for collaboration to promote these shared interests education and research, and mutual exchange of training and research expertise in clinical pharmacology and translational science. | American Society of Nephrology | CDER Patrick Archdeacon (301) 796-3952 | 2012-09-06 | Indefinite | |
| 225-13-0027 | Collaborate on developing new methods to evaluate the toxicity of substances regulated by the FDA; improving the pathway for the review and approval of regulated substances; facilitating the FDA’s engagement with scientists from academia, government and industry on regulatory science questions that impact drug development and safety prediction; sharing information that is in the public domain and considered non-confidential; and publicly disseminating scientific knowledge to help bring safe and effective products to market. | ILSI Health and Evironmental Sciences Institute | CDER | 2013-09-12 | Indefinite | |
| 225-14-0006 | Establish framework for collaboration between FDA and Washington Adventist Hospital including collaborative research, public outreach, extension activities, training, and exchange of medical professionals and staff by the two organizations. | Washington Adventist Hospital | Eileen Parish, M.D. Office of the Chief Scientist (301) 796-8522 | 2008-12-16 | Indefinite | |
| 225-14-0019 | The FDA/CDRH and H-ISAC have a shared interest in encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices. The purpose of this collaboration is to establish a basis upon which to foster and improve the safety of medical devices from cybersecurity threats. | The Health Information Sharing & Analysis Center, INC (H-ISAC) | CDRH Suzanne Schwartz Deputy Director, OST (301) 796-6937 | 2020-01-31 | 2025-01-30 | |
| 225-14-012 | Collaborative health professional training, outreach, and research initiatives. | American Nurses Association | Teresa Rubio (301) 796-5113 | 2013-05-17 | Indefinite | |
| 225-14-023 | Promoting scientific progress, furthering public policy efforts, and translating innovation and discoveries into practice in the areas of medical and biological engineering. | American Institute for Medical and Biological Engineering AIMBE | CDRH Anindita Saha (301) 796-2537 | 2014-10-3 | 2019-10-2 | |
| 225-15-010 | Sets forth principles and guidelines by which the parties intend to engage in a cooperative public education program. It is the parties’ intent to promote and increase the use of health knowledge, skills, and practices by the general population in its patterns of daily living. | The National Forum for Heart Disease and Stroke Prevention | OEA/OC Helene Clayton-Jeter (301) 796-8452 | 2015-03-29 | 2020-3-28 | |
| 225-15-012 | Engage in sharing of pre-decisional nonpublic compliance and enforcement policy information is intended to improve Federal-State uniformity, cooperative regulatory activities, or implementation of Federal-State agreements. | National Association of Attorneys General | CTP Ann Simoneau (301) 796-9295 | 2015-05-29 | Indefinite | |
| 225-15-017 | Promoting scientific progress through the exchange of scientific capital to develop innovative, collaborative projects in research, education, and outreach for the purpose of fostering medical product innovation, enabling the acceleration of medical product development, manufacturing, and translational therapeutics, and enhancing medical product safety. Replaces MOU 225-05-8000. | Critical Path Institute | CDER ShaAvheree Buckman-Garner (301) 796-2600 | 2015-04-09 | Indefinite | |
| 225-16-026 | Shared interests in promoting scientific progress through exchange of scientific capital in cardio-vascular education, training, and research. | Inova Heart and Vascular Institute | Anindita Saha, CDRH 301-796-2537 | 2015-11-01 | 2021-10-31 | |
| 225-16-025 | Provide and promote FDA information in the form of FDA health consumer information to consumers. | Healheo360 | Steve Morin 301-796-0161 | 2017-03-22 | 2022-03-21 | |
| 225-16-027 | Share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine. | Society for Toxicology | Office of the Chief Scientist | 2016-12-06 | 2021-12-05 | |
| 225-17-001 | Promoting progress in the application of computer modelling and simulation in healthcare through the exchange of knowledge, information, case studies and policy. | The Avicenna Alliance for Predictive Medicine | Pras Pathmanathan, Ph.D. | 2017-05-30 | 2027-05-31 | 2023-10-13 |
| 225-17-003 | Shared interest in facilitating the successful adoption of Unique Device Identifiers (UDIs) across the healthcare device ecosystem especially with regard to the initial capture of UDI in supply chain and clinical health information technology (IT) systems. | Association of Healthcare Resource and Materials Management (AHRMM) | CDRH Terry L. Reed 301-796-6130 | 2016-10-21 | 2021-10-20 | |
| 225-17-005 | FDA and AMA will collaborate to develop and distribute educational and outreach information to physicians to help them diagnose, treat and report foodborne illnesses; and educate patients on preventing foodborne illness. | American Medical Association | CFSAN, Sharmi Das 202-402-3786 | 2016-11-08 | 2019-11-07 | |
| 225-17-008 | Partnership between FDA and FDAAA on future specific undertakings that are considered beneficial for both organizations and are directly related to FDA's mission. Replaces MOU 225-03-8004. | Food and Drug Administration Alumni Association (FDAAA) | Dayle Cristinzio and Beth Fritsch Office of External Affairs | 2016-12-02 | 2028-05-22 | 2023-05-23 |
| 225-17-019 | Establishes a framework for collaboration to facilitate existing and new mutually agreed upon programs and activities and to carry out their common goal to improve public health by stimulating and fostering medical product innovation and enabling medical product development. | Bill and Melinda Gates Foundation | RADM Carmen Maher Assistant Surgeon General Acting Assistant Commissioner for Counterterrorism and Emerging Threats, Acting Director, Office of Counterterrorism & Emerging Threats (OCET) Carmen.Maher@fda.hhs.gov | 2017-06-27 | Indefinite | |
| 225-17-020 | This MOU establishes a cooperative relationship between the American Association of Veterinary State Boards (AAVSB) and the U.S. Food and Drug Administration’s Center for Veterinary Medicine (FDA CVM), regarding the exchange of veterinarian licensure status and enforcement information. | American Association of Veterinary State Boards | CVM Michael Murphy, DVM, JD, Ph.D. Veterinary Medical Officer Michael.murphy@fda.hhs.gov | 2017-10-18 | Indefinite | |
| 225-17-022 | Establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including education and research. | Independent Laboratories Institute (ILI) / American Council of Independent Laboratories (ACIL) | Human Foods Program (HFP) Office of Inspections and Investigations Office of Food Safety System Partnerships | 2017-08-10 | 2029-11-07 | 2024-11-07 |
| 225-17-027 | Establishes a framework for this collaboration to promote shared interests, which can be pursued through areas of innovative toxicity testing, regulatory science, education and training. | The American College of Toxicity (ACT) | Office of the Chief Scientist RADM Denise Hinton, Acting Chief Scientist | 2018-04-11 | 2023-04-10 | |
| 225-17-029 | This MOU establishes a framework for the sharing of Banfield disease prevalence data in dogs and/or cats to aid CVM in determining whether a particular intended use of a proposed new animal drug meets the definition of a “minor use.” | Medical Management International, Inc. d.b.a. Banfield Pet Hospital | CVM Dorothy Bailey, DVM Director, Center for Veterinary Medicine / Office of Minor Use and Minor Species Dorothy.Bailey@fda.hhs.gov | 2019-02-27 | Indefinite (Renewed Yearly) | 2024-06-05 |
| 225-17-030 | Provide training scientists in regulatory science and policy to foster a better understanding of FDA’s work in their post-fellowship employment. Contribute to a workforce that can advance the field of regulatory science and provide leadership in this area in policy organizations, industry, academia, or the government. | Reagan-Udall Foundation | Office of the Chief Scientist Leslie Wheelock, MS, RN 301-706-8450 | 2017-10-08 | Indefinite | |
| 225-17-020 | Exchange of veterinarian licensure status and enforcement information, including information from the AAVSB licensure and disciplinary database and publicly available untitled letters and warning letters and publicly available information regarding enforcement actions FDA CVM pursues against veterinarians. | American Association of Veterinary State Boards | Michael Murphy, DVM, JD, Ph.D. 230-402-6217 | 2017-10-18 | Indefinite | |
| 225-18-007 | Share common goals, priorities, and interests in promoting awareness and understanding of gender medicine and the science of sex-based differences and through mutually beneficial exchange of information of significance to/for women’s health. Replaces MOU 225-14-8000. | Karolinska Institutet and Stockholms Läns Landsting/Hälso-Och Sjukvårdsförvaltningen (Stockholm County Council/ Healthcare Administration) | OWH Pamela E. Scott, Ph.D. (301) 796-9440 | 2018-02-02 | 2023-02-02 | |
| 225-18-008 | Collaborate to promote scientific progress in innovation, patient education, drug safety communications, training, research, including risk evaluation and mitigation strategies (REMS), and adverse event reporting. | National Organization for Rare Disorders | Andrea Furia-Helms, OMPT 301-796-8455 | 2018-02-20 | 2021-02-20 | |
| 225-18-009 | Collaboration to promote the inclusion of diverse women in clinical trials | Society for Clinical Research Sites | Pamela Scott, Ph.D., OWH 301-796-0530 | 2018-03-05 | 2019-03-05 | |
| 225-18-011 | The purpose of the collaboration is to improve the safety of the American public when using FDA-regulated medical products. This MOU establishes the terms for collaboration to promote these shared interests. | American Society of Health-System Pharmacists | Office of External Affairs Lubna Merchant (301) 796-5162 | 2018-04-26 | 2021-04-26 | |
| 225-18-012 | Establishes the terms for collaboration to promote scientific progress through exchange of scientific capital in medication error prevention and medication safety including risk evaluation and mitigation strategies (REMS) and related implementation, MedWatch adverse event reporting, scientific education, training and research programs. | The American Pharmacist Association | CDER/OSE | 2021-10-05 | Indefinite | |
| 225-18-20 | Shared interest in promoting scientific progress in diverse disciplines that affect human and animal health and medicine. | Institute of Quantitative Systems Pharmacology | CDER Padmaja Mummaneni, PhD. 301-796-2027 | 2018-06-19 | 2023-06-19 | |
| 225-18-024 | To have a shared interest in scientific progress in the diverse disciplines and indirectly affect human and animal health and medicine. The Parties also endorse scientific training for faculty and staff to foster a well-grounded foundation in interdisciplinary fields in which academia and government share mutual interest. | St. Jude Children’s Research Hospital | CDER, Padmaja Mummaneni | 2018-10-09 | Indefinite | |
| 225-18-028 | Established to promote a shared interest to encourage the identification, mitigation, and prevention of cybersecurity threats to medical devices. | Health Information Sharing & Analysis Center and MedISAO | CDRH CDRH | 2018-09-14 | 2023-09-14 | |
| 225-18-030 | Established to promote a shared interest to encourage the identification, mitigation, and prevention of cybersecurity threats to medical devices. | Health Information Sharing & Analysis Center and Sensato Critical Infrastructure ISAO | CDRH CDRH | 2018-09-30 | 2023-09-30 | |
| 225-19-004 | This MOU provides a framework for coordination and collaboration to promote the best science and practices associated with food chemistry and regulatory science. | American Chemical Society | CFSAN Sharon Elyashiv-Barad, Ph.D. Lead Chemist (Chemistry Review Branch 1) Division of Food Contact Substances Office of Food Additive Safety Center for Food Safety and Applied Nutrition 240-402-1400 | 2019-06-04 | 2024-06-04 | 2024-08-01 |
| 225-19-023 | Promote shared interests in various science-based initiatives, outreach, training, fellowships/internships, research and scientific education to advance health equity. | The Alliance of Multicultural Physicians [a collective of five national organizations - The Association of American Indian Physicians (AAIP), Association of Black Cardiologists (ABC), National Council of Asian Pacific Islander Physicians (NCAPIP), National Hispanic Medical Association (NHMA), and National Medical Association (NMA)] | Office of Minority Health and Health Equity (OMHHE) CDR Yvonne Santiago (240) 753-5808 | 2019-07-24 | Indefinite | 2023-04-13 |
| 225-19-024 | The purpose of the collaboration is to improve the safety of the American public when using FDA‐regulated medical products. | National Council for Prescription Drug Programs | CDER Claudia Manzo, Director Office of Medication Error Prevention and Risk Management Office of Surveillance and Epidemiology Claudia.Manzo@fda.hhs.gov | 2019-06-17 | 2025-01-31 | 2022-01-31 |
| 225-20-009 | This MOU between FDA and the Foundation will expedite collaborative research and data collection efforts related to COVID-19. Under this MOU, FDA and the Foundation will seek opportunities to participate in collaborative research related to COVID-19 data collection. | Reagan-Udall Foundation for the FDA | Trudy Lilly/OC/Senior Policy Coordinator trudy.lilly@fda.hhs.gov | 2021-04-13 | 2022-04-13 | |
| 225-20-013 | To establish the FDA-AACR Oncology Educational Fellowship, as well as other collaborative educational efforts, as appropriate. The FDA and AACR share interests in promoting scientific progress through exchange of scientific knowledge in oncology education, collaborative learning, and research. Both institutions foresee benefits from the mutual exchange of educational expertise in translational oncology drug development and regulatory policy. | American Association for Cancer Research | Oncology Center of Excellence Jennifer Gao Associate Director for Education 10903 New Hampshire Ave, WO 22/2135 Silver Spring, MD 20993 Jennifer.gao@fda.hhs.gov 240-402-4683 | 2020-05-28 | 2025-05-28 | |
| 225-20-014 | FDA and AMA will collaborate to develop and disseminate educational and outreach information to physicians on dietary supplements. | American Medical Association | CFSAN Sharmi Das Director, Division of Education, Outreach, and Information 5001 Campus Drive College Park, MD 20740 Sharmi.Das@fda.hhs.gov 240-402-3786 | 2020-05-27 | 2025-05-27 | |
| 225-21-004 | FDA and the Truth Initiative will share research and scientific information to increase our understanding about e-cigarettes and new tobacco products to improve youth prevention campaign messages and cessation tools. | Truth Initiative | CTP Office of Health Communications and Education Dr. Tesfa Alexander Director, Division of Research and Evaluation Tesfa.Alexander@fda.hhs.gov 301-796-7745 | 2020-11-01 | 2025-10-31 |
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