The U.S. Food and Drug Administration (FDA) awarded a $1,000,000.00 definitive contract to the Regents of the University of Michigan to conduct research on the "Influence of Raw Materials Manufacturing Variables and Storage Conditions on Release Performance of Long Acting Release Microsphere Products." This is a cost-no-fee contract with a completion date of September 29, 2019. The University of Michigan is a U.S. Government Entity providing educational services and has extensive...
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 $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....
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...
The Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order contract valued at $51,942.80 to the Regents of the University of Michigan to provide DNA isolation and 16S rRNA sequencing for microbiome analysis of murine (mouse) fecal samples. The contract has a period of performance through March 27, 2024. This requirement was sole-sourced to the University of Michigan, which has extensive experience providing research and development services to federal agencies including the...
This $4,714,475.00 definitive, firm-fixed-price federal contract was awarded by the U.S. Food and Drug Administration (FDA) to the Massachusetts Institute of Technology (MIT) to conduct research and development on mechanistic modeling and process analytical technology for exosome production. The work is being performed in Cambridge, Massachusetts and will be completed by September 29, 2026. This contract was competitively awarded and is not designated as a set-aside. The original solicitation...
The U.S. Food and Drug Administration (FDA) awarded a $1,530,889.00 definitive, cost-no-fee contract to the University of Connecticut (UConn) to conduct research on "Investigating the Impact of API Purity, Excipient Source and Manufacturing Process on Performance and Quality of Complex siRNA Lipid Nanoparticles". This is a 4-year contract running from September 2023 to September 2027. UConn, a non-profit research university, will be the prime contractor with no set-aside designation....
The U.S. Food and Drug Administration (FDA) awarded a $696,359 firm-fixed-price contract to Duke University's Office of Research Administration Division to conduct research and development activities in support of regulatory science and innovation. The contract, which does not have a set-aside designation, originated from a Broad Agency Announcement (BAA) that solicits advanced proposals across nine key areas to advance scientific knowledge in support of the FDA's mission to protect public...
The University of Connecticut (UConn) has been awarded a $1,103,886 firm-fixed-price definitive federal contract by the Food and Drug Administration (FDA) for research and development related to the impact of active pharmaceutical ingredients on in situ forming implants and understanding in vitro and in vivo performance differences. This contract, which has a completion date of September 29, 2026, was issued under the FDA's Broad Agency Announcement for research and development to support...