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MEMORANDUMS OF UNDERSTANDING
DOMESTIC
Ensure the safety, efficacy, and quality of medical products regulated by FDA and procured for the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
U.S Department of State
OIP PEPFAR LiaisonEmail
2016-04-15
Indefinite
Modernizing regulatory science to support the development of useful medical products.
Defense Advanced Research Projects Agency
Carlos Pena, PhD, MS, CDRH (301) 796-6610
2016-04-13
2025-09-12
This MOU serves to confirm the mutual interest of the Parties to discuss and explore collaborative opportunities in supporting translational and regulatory science, including but not limited to joint financial support for applications submitted in response to the Clinical and Translational Science Awards (CTSA) Collaborative Innovation Awards program.
National Center for Advancing Translational Sciences
CDER Office of Translational Sciences Chekesha S. Clingman, Ph.D., M.B.A. Special Assistant to the Director (301) 796-8531
2016-04-13
Indefinite
Discuss and explore collaborative opportunities in supporting translational and regulatory science, including but not limited to joint financial support for applications submitted in response to the Clinical and Translational Science Awards (CTSA) Collaborative Innovation Awards program, or other scientific research funded by DCI, and training initiatives.
NIH NCAT Division of Clinical Innovation (DCI)
CDER Chekesha S. Clingman, PHD, MBA (301) 796-8531
2016-04-13
Indefinite
Modernizing regulatory science to support development of useful medical products prior to use in humans.
Defense Advanced Research Projects Agency (DARPA)
CDRH Carlos Pena, PhD, MS (301) 796-6610
2016-04-13
2025-04-12
Ensure the safety, efficacy, and quality of medical products regulated by FDA and procured for the U.S. President's Emergency Plan for AIDS Relief (PEPFAR).
U.S. Agency for International Development
FDA PEPFAR Liaison Office of International ProgramsEmail
2016-04-12
Indefinite
Establishes a framework for the agencies’ coordination in support of CDC’s use of its delegated authority to develop and issue emergency use instructions (EUI) for eligible medical countermeasures (MCMs)
Centers for Disease Control and Prevention (CDC)
OCS Elizabeth Sadove, JD (301) 796-8515
2016-02-22
Indefinite
Stream and facilitate efficient categorization of investigational medical devices to support CMS's ability to make Medicare coverage determinations for investigational devices.
Centers for Medicare and Medicaid Services (CMS)
CDRH Owen Faris, PhD (301) 796-6735
2015-12-02
Indefinite
The National Toxicology Program (NTP) is an interagency program encompassing activities from the Food and Drug Administration (FDA), National Institute of Environmental Health Sciences (NIEHS) and National Institute for Occupational Safety and Health (NIOSH). This amendment extends a 2015 MOU establishing the terms of the partnership.
National Toxicology Program (NTP), National Institutes of Health's National Institute of Environmental Health Sciences (NIH/NIEHS), and Centers for Disease Control and Prevention's National Institute for Occupational Safety and Health (CDC/NIOSH)
National Center for Toxicological Research (NCTR) Goncalo Gamboa da Costa, Ph.D. Senior Science Advisorgoncalo.gamboa@fda.hhs.gov
2015-10-30
2023-06-30
Promote initiatives related to the review and use of FDA-regulated medical devices, as defined by the Federal Food, Drug and Cosmetic Act (see 21 U.S.C. § 321(h)) that utilize radiofrequency emissions or otherwise fall under the jurisdiction of the FCC.
Federal Communications Commission
CDRH Baku Patel (301) 796-5528
2015-09-11
Indefinite
This MOU provides a framework for coordination and collaborative efforts between FDA and NIDA.
National Institute on Drug Abuse (NIDA)
CDRH John Marler, M.D. Acting Clinical Deputy Director Division of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Telephone: 301-796-4221 Email: john.marler@fda.hhs.gov
2024-06-07
2029-06-07
This MOU outlines information sharing and regulatory cooperation related to intentional genomic alterations in animals subject to USDA jurisdiction.
U.S. Department of Agriculture
CVM Adam Moyer Adam.Moyer@fda.hhs.gov
2024-04-18
2029-04-18
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