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U.S. Department of Health and Human Services

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MOU 225-12-0036


I. Purpose:

The United States Food and Drug Administration (FDA) and the University of Medicine and Dentistry of New Jersey (UMDNJ) share interests in promoting scientific progress through exchange of scientific capital in the clinical pharmacology training and research program.  Both institutions foresee benefits from the mutual exchange of training and research expertise.  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 these shared interests, which can be pursued through a variety of programs, including collaborative education and research. 

II. Background:

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, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, and medical devices and the safety and security of foods, dietary supplements, cosmetics, and radiological products.  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, 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 UMDNJ will greatly contribute to FDA’s mission.

 UMDNJ, the state's university of the health sciences, is dedicated to the pursuit of excellence in: the undergraduate, graduate, postgraduate and continuing education of health professionals and scientists; the conduct of biomedical, psychosocial, clinical and public health research; health promotion, disease prevention and the delivery of health care; and service to our communities and the entire state.  UMDNJ is the nation's largest health sciences University. UMDNJ is New Jersey's state wide system of health sciences education, biomedical research and HealthCare. UMDNJ has five campuses and a network of more than 200 affiliated healthcare and educational partners spanning the state. 

This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UMDNJ.  The types of initiatives expected to develop from this MOU include:

a. Opportunity to apply for a joint fellowship program at the FDA to advance student education and matriculation into the Clinical Pharmacology professions.  One of the mechanisms to enroll students/post-doctoral trainees/residents from UMDNJ into the joint fellowship program at the FDA is through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbaticals may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Clinical Pharmacology and UMDNJ will adhere to the CDER ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter;
b. Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
c. Opportunities to convene joint meetings for education and research;
d. Research collaborations;
e. Cooperative international initiatives; and
f. Access to unique facilities and equipment for scientific endeavors.
Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority.  Before any specific collaboration is initiated or implemented, the Parties shall identify priorities and topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within UMDNJ and FDA.

III. General Provisions

a. Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
b. Institutions within UMDNJ and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
c. Proprietary and nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
d. Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason.  UMDNJ individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
e. As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.

IV. Resource Obligations: 

This MOU represents the broad outline of the Partners’ present intent to enter specific agreements for collaborative efforts in intellectual areas of mutual interest to FDA and UMDNJ .All activities undertaken pursuant to the MOU are subject to available personnel, resources, and funds.  This MOU does not affect or supersede any existing or future agreements or arrangements among the Partners.  This MOU and all associated agreements will be subject to the applicable policies, rules, regulations, and statutes under which FDA and UMDNJ operate.

V. Liaison Officers: (Provide names, titles, addresses, and phone numbers)

a. University of Medicine and Dentistry of New Jersey

Individual's name: 
Telephone Number:

b. For the Food and Drug Administration: 

Individual's name: 
Telephone Number:

Each Party may designate new liaisons at any time by notifying the other Party's 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 liaison.

VI. Terms, Termination and Modification:

This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years.  It may be renewed by mutual written agreement of both Parties.  It may be modified at any time by mutual written agreement of both Parties.  It may be terminated by either Party upon 60-day advance written notice to the other.



Signed by: Freda Zackin, Esq 
Vice President of Academic Affairs
Date: April 19,2012


Signed by: Janet Woodcock, MD
Director, CDER, FDA
Date: June 19,2012