Definitive Contract 75F40121C00020

This federal contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to the Universitat ST. Gallen, doing business as Hochschule FÜR Wirtschafts-, Rechts- UND Sozialwissenschaften (Hsg), an educational institution. The contract is a Firm Fixed Price definitive contract with a potential value of $764,418.19 and a completion date of September 29, 2023. The contract was awarded under the FDA's Broad Agency Announcement (BAA) for Advanced Regulatory...

This is a $61,418 firm fixed price contract awarded by the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to the University of Maryland, Baltimore (UMB) on July 29, 2020. The contract is for the manufacture of an in vitro component to evaluate generic and new animal drug formulations that are not systemically absorbed. The contract has no set-aside designation and is scheduled for completion on June 30, 2023. UMB is a medical research university that has...

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...

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."...

The U.S. Food and Drug Administration (FDA) awarded a $2,238,985.00 definitive contract to The George Washington University (GWU) to develop a database that allows FDA reviewers and stakeholders to share and retrieve Biological Complex Outcomes (BCOs) along with related files and technical specifications for storing, accessing, and retrieving BCOs. The contract has an ultimate completion date of September 22, 2025 and does not use a set-aside designation. GWU will provide the requested...

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...

This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration to the University of Maryland, Baltimore (doing business as the Baltimore Campus) on September 20, 2019. The $206,498.00 firm fixed-price contract is for conducting research on batch-to-batch variability of the drug product Advair, with the goal of exploring solutions for a generic bioequivalence (BE) pathway. The contract does not have a set-aside designation. As a prominent...

The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,151,037 firm-fixed-price contract to the Regents of the University of Michigan for the development of "SEAMLESS DESIGN FOR MULTICOMPONENT ENDPOINTS FOR DRUG DEVELOPMENT IN RARE DISEASES." This definitive contract, which has a completion date of September 29, 2026, does not have a set-aside designation. The University of Michigan, a prominent U.S. state government-owned educational...

This is a firm fixed-price contract awarded by the Food and Drug Administration (FDA) to the University of Liverpool, a leading research institution in the United Kingdom, for the development of a rabbit model to characterize antifungal drug resistance. The contract has a ceiling value of $633,660.92 and an ultimate completion date of September 29, 2025. The contract was awarded on September 22, 2023, and there was no set-aside designation. The contract was awarded under a Broad Agency...

This federal contract award, identified as HHSF223201610099C, was made by the Food and Drug Administration (FDA) to the University of Florida (UF) Division of Sponsored Research. The contract, valued at $764,975.37, is for a Pharmacokinetic Comparison of Locally Acting Orally Inhaled Drug Products. This work falls under the FDA's Broad Agency Announcement (BAA) program for this research area. The contract is a definitive, cost-no-fee contract, with a performance period ending on March 22,...