FDA CRADAs
Cooperative Research and Development Agreements
| CRADA No. | FDA Lead Center | FDA Principal Investigator | Collaborator(s) | Title of CRADA | Effective Date | Expiration Date |
|---|---|---|---|---|---|---|
| 2024-0043-CRD | CDRH | Arghavan Victoria Nawaby, Ph.D., M.B.A. | Bill and Melinda Gates Foundation | Development of regulatory tools to assist in breath biomarker discovery and validation for disease detection | 4/11/2024 | 4/10/2027 |
| 2024-0023-CRD | CDRH | William Vogt, Ph.D. | Foundation for Research for Information Technologies in Society IT IS | Verification and Validation of the Computational Platform Open Online Simulations for Stimulating Peripheral Activity to Relieve Conditions | 1/23/2024 | 1/23/2029 |
| 2023-0091-CRD | CDER | Paul H. Schuette, Ph.D. | CluePoints, Inc. | An Automated System To Assess Data Quality In Multicenter Clinical Trials Using Statistical Modeling And Machine Learning | 5/31/2024 | 5/31/2027 |
| 2022-0074-CRD | CBER | Zhiping Ye, M.D., Ph.D | University of Maryland, Baltimore | Maternal Immunization and Derterminants of Infant Immunity | 2/11/2023 | 2/11/2028 |
| 2022-0025-CRD | CDER | Mitra Ahadpour, M.D. | Yale University | Yale Community Level Emerging Substance Misuse Simulation | 2/8/2024 | 2/8/2027 |
| 2022-0024-CRD | CDER | Mitra Ahadpour, M.D. | Johns Hopkins University | JHU- Community Level Emerging Substance Misuse Simulation | 8/5/2022 | 11/9/2026 |
| 2021-0032-CRD | CBER | Margaret Bash, Ph.D. | Henry M. Jackson Foundation | Assessing the effectiveness of Neisseria meningitidis Outer Membrane Vesicles (Nm-OMV) Based Vaccines as Gonorrhea Vaccines | 3/19/2021 | 3/27/2027 |
| 2021-0008-CRD | HFP | Timothy V. Duncan, Ph.D. | Fermi Research Alliance, LLC | CFSAN - Duncan and Fermi Lab (DOE) CRADA on E-Beam Irradiation of Polymer Nanocomposite Materials | 8/26/2021 | 8/26/2027 |
| 2020-0134-CRD | CBER | Hira Nakhasi, Ph.D. | Ohio State University | Production, evaluation and use of leishmanin skin test for detection of Leishmania exposure and immunity | 6/10/2020 | 8/15/2026 |
| 2020-0016-CRD | CBER | Konstantin Chumakov, Ph.D. | PATH-Program for Appropriate Technology in Health | Amended 5 times: CRADA with PATH to Develop Assay for Poliovirus Variants in Vaccine Candidates | 12/17/2019 | 10/31/2026 |
| 2019-0062-CRD | CBER | Chintamani Atreya, Ph.D. | Cerus Corporation | Optimization of Pathogen Inactivation (PI) Treatment of Whole Blood (WB): Further Research Towards Safer and More Efficacious Blood Products- 4th Amendment | 5/8/2019 | 9/30/2027 |
| 2018-0062-CRD | CDRH | Aldo Badano, Ph.D. | Barco NV | In Silico Modeling of Human Skin for Facilitating the Performance Evaluation of Skin Cancer Diagnostic Devices | 11/20/2018 | 11/20/2027 |
| 2018-0031-CRD | CBER | Arifa Khan, Ph.D. | University of Delaware | Amended three times: Umbrella CRADA with NIIMBL- Research, Development, Testing, and Training in Advanced Manufacturing | 7/15/2019 | 4//30/2027 |
| 2017-0065-CRD | CDER | Sean Khozin, Ph.D. | Apple, Inc. | NCI Lead: A Feasibility Study in a Clinical Trial Setting, Utilizing Apple's Proprietary Mobile Sensor Technologies to Assess Symptomology of Patients Enrolled on Clinical Protocols Within the NCI's Intramural Clinical Research Program | 05/18/2018 | 05/18/2029 |
| 2016-0007-CRD | CDER | Daniela Verthelyi, Ph.D. | Drugs for Neglected Diseases initiative (DNDi) | THIRD AMENDMENT Development of CpG ODN D35 for the Treatment of Cutaneous Leishmaniasis and PKDL | 12/17/2015 | 12/17/2026 |
| 2013-0044-CRD | OC/OIMT | J. Lowell Marshall | Health Canada | Amendment #5 -- US-Canada Regulatory Cooperation Council Initiative: Common Electronic Submissions Gateway | 1/10/2013 | 1/11/2028 |
| 2011-0021-CRD | OCS/OARL | Laurenee London | The United States Pharmacopeial Convention (USP) | Amended 5 times- Collaboration between the United States Pharmacopeia and Office of Regulatory Affairs/Food and Drug Administration | 3/3/2011 | 3/3/2029 |
| 2006-0045-CRD | ODT/ODAR | Elaine Johanson, Ph.D., Larry Callahan, Ph.D., Frank Switzer, Ph.D. | The United States Pharmacopeial Convention (USP) | Amended 4 times- Substance Registration Project (ODT/ODAR) | 5/23/2006 | 9/30/2029 |