The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $505,858.00 Definitive Contract to Uppsala Universitet, an educational institution and state-controlled institution of higher learning, for the "Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products." The contract is a Firm Fixed Price agreement without a set-aside designation. Uppsala Universitet will provide scientific and research...
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...
This is a $3,526,785.00 definitive, firm fixed-price contract awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan, doing business as the University of Michigan, for Prediction of In Vivo Performance Analysis Services. The contract has no set-aside designation. The University of Michigan is providing a range of research and development services under this contract, including developing high-performance computational models to simulate small intestine...
This is a $500,000 firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA) to the University of Florida (UF) Division of Sponsored Research for a pharmacokinetic comparison study of locally acting orally inhaled drug products. The contract does not have a set-aside designation, indicating UF competed for and was awarded the contract based on its extensive research capabilities. UF is a major research institution that provides a wide range of goods and services to...
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,...
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 Department of Health and Human Services Food and Drug Administration awarded a firm-fixed-price definitive contract to the University of Bath, a private university located in the United Kingdom, with a potential value of $353,765.00. The contract, which does not have a set-aside designation, is for research and educational services to be completed by August 31, 2022. Based on the vendor's past performance, the University of Bath has provided research services in areas such as physics,...
This definitive contract awarded by the Food and Drug Administration (FDA) to Texas A&M University System Health Science Center Finance And Business Services Division is valued at $300,255 to develop an in-vitro quality metrics approach for bioequivalence demonstration between intramammary infusion products for animals. The work directly responds to the FDA's Fiscal Year 2022 Broad Agency Announcement for Advanced Research and Development of Regulatory Science, which sought proposals...
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 U.S. Food and Drug Administration (FDA) awarded a Firm Fixed Price Definitive Contract worth $386,781.00 to Johannes Gutenberg-Universitat Mainz, also doing business as UNI Mainz, a state-controlled institution of higher learning. The contract is for a Broad Agency Announcement (BAA) to "Improve Scientific Approaches to Evaluate Generic Drugs". The contract has an ultimate completion date of June 30, 2025 and was awarded on July 27, 2021. No set-aside was used for this award.