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  5. FDA CRADAs
  1. Cooperative Research and Development Agreements (CRADAs)

FDA CRADAs

CRADA No. FDA Lead Center FDA Principal Investigator Collaborator(s) Title of CRADA Effective Date Expiration Date
2022-0028-CRD  CBER Konstantin Chumakov, Ph.D.  PATH-Program for Appropriate Technology in Health Next Generation Sequencing for quality control of poliovirus vaccines 8/1/2022 8/1/2024
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 3/21/2023
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
2020-0038-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
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
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