This federal contract, awarded by the Food and Drug Administration (FDA) to the Regents of the University of Michigan, is a $2,235,290.00 firm fixed-price definitive contract to conduct a comprehensive study on stimulant and opioid use and use disorder trajectories and associated consequences in U.S. adults. The contract does not have a set-aside designation. The University of Michigan, as the prime contractor, will leverage its extensive research capabilities to carry out this study. Two...
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...
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...
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...
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 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 definitive firm fixed price contract valued at approximately $1.1 million to Denver Health and Hospitals Authority for an evaluation of stimulant abuse in the United States. Denver Health will deliver a mosaic epidemiology study to assess stimulant abuse patterns across the country under the two-year contract set to run from September 2020 through September 2022. As the prime contractor, Denver Health will...
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 $978,324 definitive contract awarded by the Food and Drug Administration (FDA) to The General Hospital Corporation, doing business as Massachusetts General Hospital (MGH), for a 2-year period ending in April 2025. The contract is to enhance the FDA's Source Model by incorporating and analyzing state and regional-level data. The contract was awarded under a Broad Agency Announcement (BAA) that solicits advanced research and development proposals to support FDA regulatory science...