FDA CRADAs
| CRADA No. | FDA Lead Center | FDA Principal Investigator | Collaborator(s) | Title of CRADA | Effective Date | Expiration Date |
|---|---|---|---|---|---|---|
| 2022-0020-CRD | CBER | Karen Elkins, Ph.D. | Regents of the University of New Mexico for its Health Sciences Center, School of Medicine |
Evaluation of a tularemia vaccine candidate using a functional correlate assay |
4/1/2022 | 4/1/2023 |
| 2021-0032-CRD | CBER | Margaret Bash, Ph.D. | Henry M. Jackson Foundation, et al | 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 |
CFSAN | 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 | 8/26/2024 |
| 2020-0142-CRD | CBER | Chava Kimchi-Sarfaty, Ph.D. | Cleveland State University | Safer and More Effective Factor IX Therapeutics: Impact of Codon Optimization | 8/28/2020 | 9/30/2024 |
| 2020-0141-CRD | CBER | Hira Nakhasi, Ph.D. | Ohio State University | Evaluation of the Safety and Efficacy of Centrin Gene Deleted Mutants of Leishmania Major, Dermotropic Strains of the Blood Borne Human Pathogen Leishmania | 7/28/2020 | 7/28/2022 |
| 2020-0135-CRD | CDER | Daniela Verthelyi, Ph.D. | Merck Sharp & Dohme, Corp. | Use of a Macaque Skin Model to Determine the In-vivo Impact of Aggregation of Therapeutic Proteins on Innate Immune Responses and Product Immunogenicity | 7/8/2020 | 7/8/2023 |
| 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 | 6/10/2022 |
| 2020-0038-CRD | CFSAN | Donna Mendrick, Ph.D. | Emulate Inc. | OC - Emulate Human Emulation System Utilization | 3/2/2020 | 3/2/2023 |
| 2020-0016-CRD | CBER | Konstantin Chumakov, Ph.D. | PATH-Program for Appropriate Technology in Health | CRADA with PATH to Develop Assay for Poliovirus Variants in Vaccine Candidates | 12/17/2019 | 11/30/2022 |
| 2019-0245-CRD | CDER | Shirley Seo, Ph.D., Doanh Tran, Ph.D., and Shiew Mei Huang, Ph.D. | Bill and Melinda Gates Foundation | GATES - Exposure-based paradigm to develop long acting contraceptives | 11/11/2019 | 11/11/2024 |
| 2019-0098-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 | 3/6/2020 | 3/6/2025 |
| 2019-0062-CRD | CBER | Chintamani Atreya, Ph.D. | Cerus Corporation | Amended Once Optimization of Pathogen Inactivation (PI) Treatment of Whole Blood (WB): Further Research Towards Safer and More Efficacious Blood Products | 5/8/2019 | 5/7/2024 |
| 2019-0026-CRD | CBER | Tod Merkel, Ph.D. | Tulane University of Louisiana | Development of Outer Membrane Vesicles as a Novel Adjuvant | 5/1/2019 | 5/1/2025 |
| 2018-0135-CRD | NCTR | Minjun Chen, Ph.D. | Elsevier | Integrating pharmacokinetics and adverse effects data from the agency approval documents in Pharmapendium database with the rule-of-two model to improve the assessment of hepatotoxicity risk | 10/8/2019 | 9/30/2024 |
| 2018-0131-CRD | CBER | Chintamani Atreya, Ph.D. | Canary, Inc. | Stored Platelet Safety from Microbes: Evaluation of Microbicidal Potential of a 405-nm Light Emitting Prototype Pathogen Reduction Device | 3/18/2019 | 3/18/2024 |
| 2018-0122-CRD | CBER | Margaret Bash, Ph.D. | Regents of the University of Minnesota | Quantifying the Breadth and Duration of Immunity Induced by Meningococcal B Vaccines | 6/27/2019 | 6/27/2024 |
| 2018-0085-CRD | CBER | Chava Kimchi-Sarfaty, Ph.D. | Boston Children's Hospital | Development and evaluation of a truncated recombinant ADAMTS13 microparticle with extended release and enhanced protease plasmatic activity | 3/6/2019 | 3/6/2024 |
| 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 | 11/20/2022 |
| 2018-0041-CRD | CDRH | Wolfgang Kainz | Foundation for Research for Information Technologies in Society (ITIS) | Verification and Validation of the Computational Platform Open Online Simulations for Stimulating Peripheral Activity to Relieve Conditions | 6/19/2018 | 6/19/2023 |
| 2018-0031-CRD | OC/OCET | James Coburn, Michael Mair, Robert Orr | University of Delaware | Research, Development, Testing, and Training in Advanced Manufacturing | 7/15/2019 | 7/15/2024 |
| 2017-0068-CRD | CBER | Tod Merkel | Regeneron Pharmaceuticals, Inc. | Evaluation of the Il-4rα Blockade as an Adjuvant to Acellular Pertussis Vaccine in the Baboon Infection Model | 5/1/2019 | 5/1/2025 |
| 2017-0065-CRD | CDER | Sean Khozin, Ph.D. | Apple, Inc. | 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 | 10/8/2019 | 05/18/2024 |
| 2017-0063-CRD | CDER | Joyce A. Korvick, M.D., MPH | TARGET PharmaSolutions, Inc. | Evaluating Safety and Effectiveness in the Postmarketing Environment for Newly Approved Medications in Multiple Therapeutic Areas Across Diverse Practice Settings | 3/18/2019 | 3/18/2024 |
| 2017-0047-CRD | CBER | Judy Beeler, Ph.D. | PATH-Program for Appropriate Technology in Health | Measles, mumps and rubella serology testing in support of a clinical trial to evaluate concomitant immunization with Japanese encephalitis and measles-mumps and-rubella vaccines in infants and toddlers in the Philippines | 6/27/2019 | 6/27/2024 |
| 2013-0044-CRD | OC/OIMT | J. Lowell Marshall | Health Canada | Amendment 4 -- US-Canada Regulatory Cooperation Council Initiative: Common Electronic Submissions Gateway | 1/10/2013 | 1/11/2023 |
| 2011-0021-CRD | ORA | Ian Mayers, Ph.D. | U.S. Pharmaceopeia | Collaboration between the United States Pharmacopeia and Office of Regulatory Affairs/Food and Drug Administration | 3/3/2011 | 3/3/2023 |
| 2009-0027-CRD | CDRH | Paul Jones, Ph.D. | Fraunhofer USA, Inc. (CESE) | Software Re-engineering and Forensic Analysis | 7/22/2009 | 7/22/2022 |
| 2006-0045-CRD | OCS/OHI | Elaine Johanson, Ph.D., Larry Callahan, Ph.D., Frank Switzer, Ph.D. | The United States Pharmacopeial Convention | Substance Registration Project | 5/23/2006 | 9/30/2024 |
| 2000-0022-CRD | ORA | Patricia Alcock, Ph.D. | EduNeering Holdings, Inc. (DBL- UL Quality, Compliance, and Learning) | Transitioning FDA Basic Law Course to On-line Learning | 11/4/1999 | 11/1/2024 |