The Department of Health and Human Services Food and Drug Administration awarded a $906,628.80 firm fixed price definitive contract to Universitat ST. Gallen, doing business as Hochschule Für Wirtschafts-, Rechts- und Sozialwissenschaften, to address the Broad Agency Announcement FY23C2DWP1: Predictive Continuous Improvement Acceleration towards Performance Based Regulations and Oversight. The contract responds to the FY23 FDA Broad Agency Announcement for Advanced Research and Development of...
The U.S. Food and Drug Administration (FDA) awarded a $515,769.89 firm fixed price definitive contract to the University of St. Gallen, a Swiss educational institution, to conduct research and develop tools to strengthen post-market surveillance of FDA-regulated products. The objective is to apply advanced analytics and hybrid artificial intelligence to improve risk identification. This contract was awarded under the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research...
This federal contract award was issued by the Food and Drug Administration (FDA), a civilian agency within the Department of Health and Human Services, to Florida State University (FSU) as the prime contractor. The $2,277,208 Firm Fixed Price contract was awarded on September 30, 2025 with a completion date of September 29, 2028. It was issued under the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, which solicits proposals...
The Food and Drug Administration (FDA) awarded a $527,318.00 definitive contract to Uppsala Universitet, a Swedish educational institution, to conduct research and development on model-integrated strategies for bioequivalence evaluation of drugs with high variability and/or long half-life. This contract was awarded under the FDA's Broad Agency Announcement, which seeks proposals to advance regulatory science in various areas. The contract has no set-aside designation and is intended to support...
The Department of Health and Human Services' Food and Drug Administration awarded a Firm Fixed Price Definitive Contract to Uppsala Universitet, an educational institution, for the evaluation and development of model-based bioequivalence analysis strategies. The $574,726.00 contract, which does not have a set-aside designation, was awarded on April 10, 2017 with a completion date of September 1, 2020. The contractor specializes in scientific and research services related to the development and...
The Department of Health and Human Services Food and Drug Administration awarded a $249,999.00 definitive contract to Hartford Hospital, a non-profit hospital organization, to conduct research and development in support of regulatory science and innovation. This contract was awarded under the FDA's Broad Agency Announcement for Advanced Regulatory Science for fiscal year 2021, which solicits proposals across eight areas of regulatory science to modernize FDA functions. The contract does not have...
The Department of Health and Human Services Food and Drug Administration awarded a definitive contract valued at $831,964 to Research Center Pharmaceutical Engineering GmbH. The firm fixed price contract is to provide services in support of the project titled "OCT for Real-Time Monitoring of Coating Process Dynamics & Product Quality" and will involve work by the prime contractor and its parent organization, Technische Universitaet Graz. The contract has a period of performance...
The Department of Health and Human Services Food and Drug Administration (HHS FDA) awarded a $21,750 purchase order to Howard University for research services. The firm fixed price contract has a period of performance from April 2017 to April 2019. As the prime contractor, Howard University will perform the research services out of its division located in Silver Spring, Maryland. No additional details were provided regarding the scope of work, but the FDA funds various clinical trials and...
This is a $9,671,431.00 firm fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Safe Health Systems, Inc., a self-certified small disadvantaged business. The contract is to stimulate innovation in clinical evaluations and personalized medicine to improve product development and patient outcomes. The contract has a period of performance through March 27, 2026 and does not utilize a set-aside. No additional details about larger contract...
This is a $494,060 Definitive Contract awarded by the Food and Drug Administration (FDA) to Drexel University, a private research university located in Philadelphia. The contract was awarded under the FDA's Broad Agency Announcement (BAA) seeking research and development proposals to advance regulatory science. Specifically, the contract is for the development of "machine-learning based heterogeneous treatment effect models for prioritizing product-specific guidance development."...