About FDA

Non-Profit MOUs

MOU No.PurposePartiesFDA Lead Center or Office ContactEffective DateExpiration Date
MOU 215-18-024To 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 HospitalCDER,
Padmaja Mummaneni
10-09-2018Not applicable, no expiration date
225-03-4000BFDA and NTEU agree to work together regarding mandatory foreign inspection assignments.National Treasury Employees Union (NTEU)ORA
Diana Kolaitis
(718) 662-5416
06-11-2003expires w/contract
225-04-4002FDA 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
225-10-0021Defines 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 WebMDOC/OEA
Anna Fine
(301) 796-8471
225-11-0017Defines the framework for collaboration between CDER and FDA and the Institute for Safe Medication Practices. The purpose of the collaboration is to improve the safety of the American public when using CDER-regulated products. Amendment 1 to extend timeframe. Amendment 2 to clarify point of contact for conveyance of information.Institute for Safe Medication PracticesCDER
Cynthia Fitzpatrick
(301) 796-3115
225-11-0021Establishes a strategic framework for collaboration between FDA and the Uppsala Monitoring Centre (UMC) 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 CentreCDER
Gerald Dal Pan
(301) 796-2380
225-12-0025Collaborate and involve a consortium of various stakeholders including academic, research and clinical stakeholders, advocacy groups, industry, international partners, and others who may collaborate to advance regulatory science; and foster biomedical and biotechnology innovations, in personalized medicine, health information technology, data mining analytics, post-market safety surveillance, comparative safety and efficacy analysis, and international harmonization to support FDA's mission.The IV2 Alliance, Inc.OC
Walter Harris
225-12-0038Establishes 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 NephrologyCDER
Patrick Archdeacon
(301) 796-3952
225-12-8000Promoting scientific progress through knowledge exchange of scientific capital in pharmacology and translational research.The Systems Biology InstituteCDER
Darrell Abernethy
( 301) 796-5008
225-83-3000Defines 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
225-84-2003To foster and improve the sanitation and quality of shellfish in the U.S.Interstate Shellfish Sanitation Conference (ISSC)CFSAN
Donald Kraemer
(240) 402-2300
225-93-4006CFP 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
225-93-7000Evaluating test kits for detecting animal drug residues in milkAOACCVM
Tracey Forfa
(240) 276-9006
225-13-0027Collaborate 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 InstituteCDER09-12-2013Indefinite
225-14-0006Establish 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 HospitalEileen Parish, M.D.
Office of the Chief Scientist
(301) 796-8522
225-14-012Collaborative health professional training, outreach, and research initiatives.American Nurses AssociationTeresa Rubio
(301) 796-5113
May 17, 2013Indefinite
225-14-0019Encouraging the identification, mitigation, and prevention of cybersecurity threats to medical devices.National Health Information Sharing and Analysis Center, Inc.Suzanne Schwartz, M.D., MBA
(301) 796-6937
August 26, 2014August 25, 2019
225-14-023Promoting 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 AIMBECDRH
Anindita Saha (301) 796-2537
225-14-024Promote and Provide FDA Consumer Updates on public health and safety messages on emerging issues and product recalls to consumers.Healthline.comOEA/OC
Jason Brodsky
(301) 796-8234
225-15-010Sets 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 PreventionOEA/OC
Helene Clayton-Jeter
(301) 796-8452
225-15-012Engage 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 GeneralCTP
Ann Simoneau
(301) 796-9295
225-15-017 Replace 225-05-8000Promoting 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.Critical Path InstituteCDER
ShaAvheree Buckman-Garner
(301) 796-2600
225-16-002Collaborate in educating the public about health issuesNational Consumers LeagueCDER
Kimberly Rawlings
(301) 796-3818
225-16-0026Shared interests in promoting scientific progress through exchange of scientific capital in cardio-vascular education, training, and research.Inova Heart and Vascular InstituteAnindita Saha, CDRH
225-16-025Provide and promote FDA information in the form of FDA health consumer information to consumers.Healheo360Steve Morin,
225-16-027Share interest in scientific progress in the disciplines that directly and indirectly affect human and animal health and medicine.Society for ToxicologyLuciana Borio, MD12-6-201612-05-2021
225-17-003Shared 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
225-17-005FDA 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 AssociationCFSAN,
Sharmi Das
Replaces 225-03-8004
Partnership between FDA and FDAAA on future specific undertakings that are considered beneficial for both organizations and are directly related to FDA's mission.Food and Drug Administration Alumni Association FDAAAHeidi Marchand, OC/OER
225-17-001Promoting 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 MedicineTina M. Morrison, PhD05-30-201705-31-2022
225-17-019Establishes 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 FoundationRADM Carmen Maher
Assistant Surgeon General
Acting Assistant Commissioner for Counterterrorism and Emerging Threats,
Acting Director, Office of Counterterrorism & Emerging Threats (OCET)
June 27, 2017Indefinite
225-17-022Promote scientific progress in food sciences through exchange of scientific capital in analytical methods development and validation, as well as in educational initiatives.Independent Laboratories InstitutePalmer A. Orlandi, RADM, 301-796-6592August 10, 2017August 9, 2022
225-17-027Establishes a framework for this collaboration to promote shared interests, which can be pursued through areas of
innovative toxicity testing, regulatory science, education and training.

Food and Drug Administration and the American College of Toxicity (ACT)

Office of the Chief Scientist

RADM Denise Hinton, Acting Chief Scientist

April 11, 2018April 10, 2023
225-17-029Accessing information to aid in assessing whether a particular intended use of a proposed new animal drug product meets the definition of "minor use."Banfield Medical Management International, Inc.  02-27-2018 02-27-2019
225-17-030Provide 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 FoundationOffice of the Chief Scientist
Leslie Wheelock, MS, RN
September 8, 2017Indefinite
225-17-020Exchange 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 BoardsMichael Murphy, DVM, JD, Ph.D.
October 18, 2017Indefinite

Replace 225-14-8000

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.Karolinska Institutet and Stockholms Läns Landsting/Hälso-Och Sjukvårdsförvaltningen (Stockholm County Council/ Healthcare Administration)OWH
Pamela E. Scott, Ph.D.
(301) 796-9440
225-18-008Collaborate 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 DisordersAndrea Furia-Helms, OMPT
 February 20, 2018 February 19, 2021
225-18-009Collaboration to promote the inclusion of diverse women in clinical trialsSociety for Clinical Research Sites
Pamela Scott, Ph.D., OWH
March 5, 2018March 5, 2019
225-18-012Establishes 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. Food and Drug Administration and the American Pharmacist Association

Heidi C. Marchand, OHCA

Lubna Merchant
Effective Date:

April 11, 2018April 10, 2023
225-18-028Established to promote a shared interest to encourage the identification, mitigation, and prevention of cybersecurity threats to medical devices.Health Information Sharing & Analysis Center and MedISAOCDRH
Suzanne B. Schwartz, M.D., M. B.A

Seth Carmody, Ph.D.
September 14, 2018September 14, 2023
225-18-030Established 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 ISAOCDRH
Suzanne B. Schwartz, M.D., M. B.A

Seth Carmody, Ph.D.
September 2018September 2023
225-18-20Shared interest in promoting scientific progress in diverse disciplines that affect human and animal health and medicine.
Institute of Quantitative Systems Pharmacology

Padmaja Mummaneni, PhD.





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