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....
The Department of Health and Human Services Food and Drug Administration awarded a definitive cost-no-fee contract to the Regents of the University of Michigan for $1,482,306.00. The contract is to conduct research on the influence of raw materials, manufacturing variables, and storage conditions on the release performance of long-acting release microsphere products. The contract does not have a set-aside designation. The University of Michigan is a U.S. state government educational...
This is a $400,000.00 Firm Fixed Price Definitive Contract awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan. The contract is intended 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 for specific pathogens. This contract is not associated with a set-aside designation. The contract work...
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...
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 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 definitive cost-reimbursement contract was awarded by the National Institutes of Health's National Institute on Drug Abuse to the Regents of the University of Michigan, with a period of performance from April 1, 2019 through March 31, 2024 and a potential value of five million three hundred ten thousand nine hundred fifty-three dollars. The contract supports the National Addiction and HIV Data Archive Program, under which the University of Michigan will continue archiving social science and...
This is a $1,983,363.25 cost-reimbursement contract awarded by the Department of Health and Human Services Food and Drug Administration to the Research Foundation For Mental Hygiene, Inc. The contract supports an opioid study being conducted by the New York State Psychiatric Institute division of the Research Foundation For Mental Hygiene, Inc., a not-for-profit organization that conducts mental health research and provides treatment services. The study involves a randomized, double-blind,...