The Department of Health and Human Services' Food and Drug Administration awarded a $797,837.04 definitive cost-no-fee contract to the Regents of the University of Michigan (doing business as the University of Michigan) for the PMWP#112 - Innovative Randomized Drug Trial Design Bayesian Analysis project. The contract, which does not have a set-aside designation, is for the development of analyses to support small-sample, sequential, multiple assignment randomized trials for the registration of a...
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...
The U.S. Food and Drug Administration (FDA) awarded a $400,000.00 firm-fixed price contract to the Regents of the University of Michigan, Office of Research and Sponsored Projects (University of Michigan) to advance the science of in vitro, animal model, pharmacokinetic studies, and/or real-world evidence studies to facilitate drug development, including studies focused on antimicrobial resistance and drug development. This contract has a period of performance through March 31, 2026. The...
This is a federal contract award from the Food and Drug Administration (FDA) to the Regents of the University of Michigan (University of Michigan) for the development of a "Wireless Pharmaceutical Analysis Device (WPAD) and Computational Model to Determine In Vivo Drug Dissolution in GI Tract for Distinguishing Meaningful Product Differences and Ensuring Bioequivalence." The contract is a definitive contract with a cost-no-fee pricing type and has a ceiling value of $6,343,667.39....
The Department of Health and Human Services Food and Drug Administration awarded a firm-fixed-price definitive contract to the Regents of the University of Michigan, Office of Research and Sponsored Projects, doing business as the University of Michigan, to set patient-centric quality standards (PCQS) for modified release (MR) oral drug products with biopredictive in vitro dissolution-models. The contract has a potential value of $2,212,490.00 and a completion date of September 29, 2025. The...
This is a $75,000.00 firm fixed-price purchase order contract awarded by the National Institute on Drug Abuse (NIDA), a civilian agency within the U.S. Department of Health and Human Services, to the Regents of the University of Michigan. The contract does not have a set-aside designation. The University of Michigan is a leading public research institution that has previously held prime and subcontract awards with various federal agencies, including the Department of Veterans Affairs, to provide...
This $7,369,588 federal contract was awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan. The contract is titled "In Vivo Predictive Dissolution (IPD) to Advance Oral Product Bioequivalence (BE) Regulation" and aims to develop improved methods for assessing the bioequivalence of oral drug products. The contract has three main objectives: 1) Mass transport analysis of the gastrointestinal tract, 2) Development and validation of gastrointestinal...
The Department of Health and Human Services Centers for Disease Control and Prevention awarded a $353,608 definitive contract to the Regents of the University of Michigan, which operates as the University of Michigan. This cost-no-fee contract was issued under Broad Agency Announcement 2017 and has a completion date of December 29, 2018. The contract does not have a set-aside designation. The University of Michigan is a U.S. state government entity and educational institution that has previously...
This is a federal contract award from the National Heart Lung and Blood Institute, a civilian agency within the U.S. government, to the Regents of the University of Michigan. The contract, valued at $5,080,009.37, is for biomedical research and exploration services. The contract is a definitive contract with a cost no fee pricing type, and has an ultimate completion date of July 31, 2016. The contract does not have a set-aside designation. The University of Michigan is a highly-regarded public...
This is a $1,484,606.68 definitive contract awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan to conduct research and analysis on stimulant use, misuse, and use disorder trajectories. The contract has no set-aside designation. Under the contract, the University of Michigan will coordinate with Massachusetts General Hospital and Texas State University to supplement existing drug use and health survey data with clinical data from the MGH's HEAL project....