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  1. FDA Memoranda of Understanding
MOU No. Purpose Parties FDA Lead Center or
Office/Contact
Effective Date Expiration
Date
Last Revision
Date
225-24-006 This MOU establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. University of California San Francisco (UCSF) Padmaja Mummaneni, PhD.
Office of Translational Sciences
2024-03-11 2029-03-11  
225-24-003 This MOU documents affiliation among Walter Reed, Uniformed Services University, and FDA in the established Clinical Pharmacology Fellowship Training Program. Walter Reed, Uniformed Services University, and FDA Padmaja Mummaneni, PhD.
Office of Translational Sciences (OTS)
2024-02-05 2032-07-01  
225-23-010 Establishes the FDA-ASA Oncology Educational Fellowship. Both parties share interests in promoting scientific progress through exchange of scientific knowledge in statistical methods for clinical research, oncology education, collaborative learning, and research. American Statistical Association (ASA) Oncology Center of Excellence (OCE)
Jennifer Gao M.D. 
Associate Director for Education 
10903 New Hampshire Ave, WO 22/2135 
Silver Spring, MD 20993 
Jennifer.gao@fda.hhs.gov 
240-402-4683
2023-06-06 2028-09-30  
225-23-007  This MOU establishes the terms for collaboration to promote 
FDA and MSU’s shared interests, which can be pursued through a variety of programs.
Michigan State University (MSU) CDER
Padmaja Mummaneni, PhD
(301) 796-2027
2023-08-01 2028-08-01
2023-08-01
 
225-23-002 This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and University of Pennsylvania, Perelman
School of Medicine.
Perelman School of Medicine at the University of Pennsylvania (Penn Med) Padmaja Mummaneni, Ph.D.
Consumer Safety Officer, Regulatory Health Project Manager
Center for Drug Evaluation and Research (CDER), Office of Translational Sciences, Office of Clinical Pharmacology
301-796-2027
2023-05-30 2028-05-30  
225-20-001 Maryland Montgomery County Public Schools, collaboration to foster Scientific Technology Engineering and Math studies and career paths, along with educating youth about the dangers of opioid misuse and prevention of substance abuse. Maryland, Montgomery Count Public school system CDER
Chekesha Clingman
(301) 796-8531
2020-02-12 2025-02-12  
225-93-2001 IL Inst. Tech., participation in short courses, workshops, & training programs in food safety and technology. Illinois Institute of Technology CFSAN
Don Zink
(240) 402-1693
1993-09-03 Indefinite  
225-02-8001 Establishes terms of collaboration between FDA and UMD to support shared interest in scientific progress through a variety of programs such as sabbaticals, postdoctoral fellowships, and student internships. University of Maryland OC
Eileen Parish
(301) 796-8522
2002-09-04 Indefinite  
225-03-6000 Establishes terms of collaboration between FDA and VA Polytechnic Institute to support shared interest in scientific progress through a variety of programs such as sabbaticals, postdoctoral fellowships, and student internships. University of Houston CDRH
Michelle Chenault
(240) 276-3815
2003-03-29 Indefinite  
225-03-8002 Establishes terms of collaboration between FDA and VA Polytechnic Institute to support shared interest in scientific progress through a variety of programs such as sabbaticals, postdoctoral fellowships, and student internships. Virginia Polytechnic Institute OC
Eileen Parish
(301) 796-8522
2003-03-13 Indefinite  
225-03-8003 Establishes terms of collaboration between FDA and Howard University to support shared interest in scientific progress affecting human and animal health and medicine through a variety of programs such as sabbaticals, postdoctoral fellowships, and student internships. Howard University OC
Eileen Parish
(301) 796-8522
2003-05-29 Indefinite  
225-05-6000 To establish terms of collaboration between FDA and BWH to support shared interests and to begin the initiative "The FDA Brigham Elective Program for Residents in the Department of Medicine." Brigham and Women's Hospital CDRH
Anindita Saha
(301) 796-2537
Mimi Nguyen
(301) 796-4125
2006-05-09 Indefinite  
225-05-6001 Establishes collaboration between FDA, Duke University, and Duke University Health System, Inc. in sharing scientific information. Duke University and Duke University Health System, Inc. CDRH
Annindita Saha
(301) 796-2537
Mimi Nguyen
301-796-4125
2006-09-18 Indefinite  
225-07-6001 Establishes the terms for collaborative research between the FDA and Stanford University to promote scientific progress in animal and human medicine. Amended to change POC and termination date. Stanford University CDRH
Anindita Saha
(301-796-2537
Mimi Nguyen
301-796-4125

2012-07-12
Revised on
2016-05-11

Indefinite  
225-07-8005 To establish terms of collaboration between FDA and Duke, as a part of FDA's Critical Path Initiative. This MOU will serve as the basis of a Public Private Partnership hosted by Duke to systematically modernize the clinical trial process. Duke University OC
Melissa Robb
(301) 827-1516
2007-09-22 Indefinite  
225-07-8008-1 To establish collaboration in the areas of advanced scientific training, information exchange and stimulation of cooperative research activities in biotechnology, bioethics, and nanotechnology, particularly with the Institute of NanoBioTechnology.  Replaced MOU #s 225-07-8008 and 225-02-8000. John Hopkins University OC
Eileen Parish
(301) 796-8522
2015-05-20 2020-05-20  
225-07-8405 Forms the basis for development of scientific collaborations, outreach and educational
initiatives and intellectual partnerships between FDA and USM.
University System of Maryland Office of the Chief Scientist 2018-04-02 Indefinite  
225-11-0024 Establishes a collaborative framework between the FDA and the University of Florida through a variety of programs, including collaborative education and research. Term Extension Modification. University of Florida CDER
Ryan Chatman
(301) 796-2106
2011-09-21 2021-09-19  
225-12-0004 Establishes the collaboration between The United States Food and Drug Administration (FDA) and Thomas Jefferson University to share interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Program. Time Extension Amendment The Thomas Jefferson University CDER
Ryan Chatman
(301) 796-2106
2011-12-09 2021-12-09  
225-12-0011 Forms the basis for the initial relations between FDA and the University of Hawaii, College of Pharmacy for sabbaticals, research and scientific education University of Hawaii Hilo, College of Pharmacy OMH
Richardae Araojo
(301) 796-8000
2012-03-30 Indefinite  
225-12-0012 Forms the basis for the initial relations between FDA and the University of Hawaii for sabbaticals, research and scientific education. University of Hawaii at Manoa, Office of Public Health Studies OMH
Richardae Araojo
(301) 796-8000
2012-04-24 Indefinite  
225-12-0018 Establishes the terms between the Food and Drug Administration (FDA) and Stanford University (Stanford) to promote scientific progress through exchange of scientific capital in diverse fields of science that affect human and animal health and medicine. Stanford University CDER
Gerald J. Dal Pan, MD, MHS
301-796-2380
2012-05-17 Indefinite  
225-12-0029 Forms the basis for the initial relations between FDA and Meharry Medical College (Meharry) for sabbaticals, research and scientific education. Meharry Medical College OMH
Richardae Araojo
(301) 796-8000
2012-06-21 Indefinite  
225-13-002 This MOU establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research.
 
Harvard T.H. Chan School of Public Health CDER
Scott N. Goldie
General Health Scientist
(301) 796-2055
 
2018-01-18 2021-01-18  
225-13-0025 Establishes terms of collaboration between FDA and the University of Hamburg for development of scientific collaborations, outreach and educational initiatives, and intellectual partnerships. University of Hamburg CFSAN
Eric Brown, PhD
(240) 402-2020
2013-09-05 Indefinite  
225-14-007 This Memorandum of Understanding (MOU) states the mutual intention of the parties to seek opportunities for collaboration and to promote shared interests in various science-based academic initiatives, fellowships, and student internships. York College of the City University of New York OMH
Richardae Araojo
(301) 796-8000
2014-02-20 Indefinite  

225-15-006

Collaboration to promote these shared interests, which can be pursued through information sharing in regulatory science research, training, sabbaticals, postdoctoral fellowships, and student internships. Morehouse School of Medicine OMH
Richardae Araojo
(301) 796-8000
2014-12-22 Indefinite  
225-15-013
 
Shared interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Programs. This was amended to extend the termination date to June 30, 2021. University of California at San Diego CDER 

2012-06-30

Revised on:
2018-05-08,
2021-08-06

2026-08-06  
225-16-001
Identify indicators of cardiovascular risk, predict adverse cardiovascular events associated with therapeutic interventions, and improve the clinical utility of biomarker technologies as diagnostic and assessment tools that facilitate developing safer and more effective cardiovascular therapies, diagnostic and assessment tools.
Duke University Cardiac Safety Research Consortium Norman Stockbridge, MD, PhD
(301) 796-9841
2015-10-28 Indefinite  
225-16-005
Establish opportunities for scientific and medical exchange between the FDA scientific staff and the University’s science students and academicians through collaborative research and training.
University of Rochester OCS
Eileen Parish, M.D.
(301) 796-8522 
2015-12-14 2020-12-14  
225-16-006 To establish a mutually acceptable agreement between FDA and Cornell that will provide for collaboration on the development and delivery of training to FDA and State, Local, Tribal, and Territorial inspection personnel. Cornell University ORA
Patricia L. Alcock
Director, Division of Human Resource Development
301-796-4299
2015-12-18 2020-12-18  
225-16-014 Promote scientific capital, training, research, training, and research expertise. Information sharing in regulatory science research, training, sabbaticals, postdoctoral, recruitment opportunities, fellowships, and student internships. Rutgers University ORA
Paula Davy
(718) 340-7942
Nazmul Hassan
(718) 62-5707
2016-01-26 2026-01-26 2021-04-14
225-16-021 Establishes terms for collaboration through a variety of programs, e.g., research, graduate student training, and exchange of scientists, exchange of staff, sabbaticals, post-doctoral fellowships, and student interns. Worcester Polytechnic Institute CDER
Gerald J. Dal Pan, MD, MHS, CDER
301-796-2380
2016-08-25 Indefinite  
225-16-023 Promote share interests in collaborative education and research. Virginia Commonwealth University Padmaja Mummaneni, Ph.D.
301-796-2027
2016-08-16 2027-11-08 2022-11-08
225-16-030 To facilitate existing and new mutually agreed upon programs and activities to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. The University of Alabama’s School of Medicine, Department of Neurology CDER
Padmaja Mummaneni, Ph.D.
10902 New Hampshire Avenue, White Oak Building 51
Silver Spring, MD
(301) 796-2027
2016-12-06 2021-12-06  
225-17-002 Shared interests in promoting scientific progress through exchange of scientific capital in Clinical Pharmacology Training and Research Programs.  Replaced MOU 225-11-0006. University of California San Francisco CDER
Padmaja Mummaneni,
301-796-2027
2016-10-9 2021-10-08  
225-17-010 This MOU establishes the terms for collaboration between FDA and HCV-TARGET to promote shared interests, which can be pursued through a variety of programs including collaborative
research.
HCV-TARGET, the University of Florida, and the University of North Carolina at Chapel Hill CDER
Poonam Mishra, M.D., MPH
Division Director (Safety)
Division of Antiviral Products
Office of New Drugs
2017-02-16 2020-02-16  
225-17-017 FDA and GUMC share interests In promoting scientific progress through the exchange of scientific capital in the diverse disciplines that directly and Indirectly affect human and animal health and medicine. Georgetown University Medical Center Khaled Bouri, Ph.D.
Office of Regulatory Science and Innovation, Office of the Chief Scientist
301-796-8476
2017-06-09 2022-06-09  
225-17-024 To facilitate existing and new mutually agreed upon programs and activities and establish the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. University of Washington School of Pharmacy

CDER
Padmaja Mummaneni, PhD
(301) 796-2027

2017-09-26 2022-09-26-  
225-17-026 Promote scientific progress through exchange of scientific capital
to enhance the assessment of safety and efficacy of FDA-regulated products through joint educational and training fellowship programs.
Duke University CDER
Padmaja Mummaneni, PhD
301-796-2027 
 
2017-08-03- 2022-08-02  
225-17-032 This MOU establishes terms for collaboration to promote shared interests, which may be pursued through a variety of programs including collaborative education and research. University of Utah CDER
Padmaja Mummaneni
10903 New Hampshire Avenue
FDA White Oak Building 51, Room 2164
Silver Spring, MD 20993-0002
Telephone Number: 301-796-2027
2017-10-18 2022-10-18  
225-17-033 This MOU establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. University of North Carolina at Chapel Hill CDER
Scott Goldie, Ph.D.
10903 New Hampshire Avenue
Building 21 Room 3557
Silver Spring, MD 20993
(301) 796-2055
2017-09-14 Indefinite  
225-17-034 The collaborative framework this MOU provides will facilitate existing and new mutually agreed upon programs and activities and establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. Stanford University School of Medicine, Department of Bioengineering CDER
Padmaja Mummaneni, PhD
10903 New  Hampshire Avenue White Oak Building 51, Room 2164
Silver Spring, MD 20993-0002
(301) 796-2027
2017-10-06 2022-10-06  
225-17-035 The parties want to collaborate on biomedical engineering projects of importance to the regulatory science priorities at CDRH. Zhang Bioengineering Laboratory, Clemson University CDRH
Edward Margerrison, Ph.D., Director
Office of Science and Engineering Laboratories
Edward.Margerrison@fda.hhs.gov
2017-09-15 2022-09-15  
225-17-036 This MOU and the collaborative framework it provides will facilitate existing and new mutually agreed upon programs and activities, consortia and consensus development between the parties and establishes the terms for collaboration to promote shared interests. Rutgers School of Health Professions CDER
Padmaja Mummaneni, Ph.D.
Consumer Safety Officer
10903 New Hampshire Avenue White Oak Building 51,
Room 2164
Silver Spring, MD 20993
(301) 796-2027
2017-10-16 2027-10-16 2023-05-19
225-17-037 This MOU establishes the terms for collaboration to promote FDA and University of Pittsburgh’s shared interests, which can be pursued through a variety of programs. University of Pittsburgh CDER
Padmaja Mummaneni, PhD
(301) 796-2027
2018-01-18 2028-01-18 2023-05-15
225-18-001 This MOU establishes the terms for collaboration to promote shared interests, which can be pursued through a variety of programs including collaborative education and research. Vanderbilt University Medical Center (VUMC) CDER
Scott N. Goldie, Ph.D.
Special Assistant for the Office of Biostatistics
10903 New Hampshire Avenue,
Building 21 Room 3577
Silver Spring, MD 20993
2017-10-30 Indefinite  
225-18-004 Establishes terms of collaboration between FDA and UMBC to support collaboration on specific projects related to biotechnology process validation, but can serve as a basis for future collaboration in other areas. University of Maryland, Baltimore County CDER
Dr. Kurt Brorson
(301) 796-2193
2003-07-25 Indefinite  
225-18-013 Establishes a framework for this collaboration to enhance mutual cybersecurity and technology related interactions in education and research. Montgomery College Office of the Chief Information Officer
Craig Taylor
301-796-8696
2018-03-28 Indefinite  
225-18-015 Promote shared interests in various science-based academic initiatives, fellowships, internships, sabbaticals, research and scientific education. Yale University Office of Minority Health
CAPT Richardae Araojo
301-796-1152 
2018-03-28 Indefinite  
225-18-016 Shared interests in promoting scientific progress through exchange of scientific capital in public health, epidemiology and research. State University of New York at Buffalo Office of Minority Health/OC
Yeruk (Lily) Mulugeta
301-796-3162
2018-05-14 2023-05-13  
225-18-021 Promotes scientific progress through exchange of scientific capital in clinical pharmacy and pharmacology training, research programs, clinical research in pharmacotherapy, biopharmaceutics, clinical pharmacology and translational science. University of Georgia CDER 2018-08-28 2028-08-24 2023-10-03
225-18-029 Collaborate on biomedical engineering projects of importance to the regulatory science priorities at CDRH. The parties have an interest in better understanding the bioengineering performance of many regulated medical and surgical devices. University of Kentucky CDRH
Edward Margerrison, Ph.D.
2018-09-18 2023-09-18  
225-19-003 The purpose of MOU 225-19-003 is to establish a framework for collaborative educational, research and training opportunities.  The joint efforts will be undertaken to develop collaborative research and training programs as permitted under appropriate statutory authority.
 
Massachusetts Institute of Technology OC
Sean Khozin, MD, MPH
2019-01-30 2024-01-30  
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  

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Domestic MOUs

Agreements between FDA and other domestic government entities, including federal, state, and local agencies.


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