This is a $787,013 cost-reimbursement contract awarded by the Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization, for the "Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers." The contract, which does not have a set-aside designation, was awarded on September 8, 2016 and has a completion date of June 29, 2019. C-Path's work under this contract involves collaborating with industry, academia, and patient...
This definitive, firm fixed-price contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to CFD Research Corporation, a for-profit organization, to develop a multiscale computational framework for assessing the bioequivalence of orally inhaled drugs. The $499,761 contract does not have a set-aside designation. The original solicitation was a Broad Agency Announcement (BAA) seeking research and development to advance FDA's mission of protecting...
<p>This is a $580,000.00 Firm Fixed Price contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to F2G LTD, a for-profit organization, on September 29, 2021. The contract is for the creation and validation of a Patient Reported Outcome (PRO) instrument to assess health-related quality of life in patients with coccidioidomycosis. The contract has an ultimate completion date of October 30, 2024 and does not utilize a set-aside designation.</p>
This is a firm-fixed-price purchase order awarded by the Food and Drug Administration (FDA) to Children's Research Institute, a pediatric research organization affiliated with Children's National Medical Center. The $176,933.97 contract is for "ADVANCING FETAL PHARMACOLOGY THROUGH REGULATORY SCIENCE" (PERINATAL HEALTH CENTER OF EXCELLENCE) and has a completion date of September 19, 2023. There is no set-aside designation for this award. Children's Research Institute has a strong...
The U.S. Food and Drug Administration (FDA) awarded a $901,888.19 definitive contract to the National Academy of Sciences (NAS), a non-profit organization, to produce a consensus report that identifies innovative technologies to advance pharmaceutical manufacturing. The contract, which is not set aside, was awarded on July 19, 2019 with a completion date of March 31, 2022. The report will assist the FDA's Center for Drug Evaluation and Research (CDER) in fostering the adoption of innovative...
The Department of Health and Human Services Food and Drug Administration awarded a $3.1 million definitive contract to St. Jude Children's Research Hospital Inc. to conduct modeling of pediatric solid tumors and the tumor microenvironment. This contract was awarded under the agency's fiscal year 2021 Broad Agency Announcement for Advanced Regulatory Science, which sought proposals across eight areas of regulatory science including strengthening social and behavioral research. There was no...
The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,275,361.26 definitive cost-no-fee contract to Alliance Nctn Foundation, a non-profit organization and foundation, to conduct the "Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Data Capture and Standardization Study". This contract, with a performance period ending on September 29, 2024, is part of the FDA's broader efforts to advance regulatory science and support public...
The U.S. Food and Drug Administration (FDA) awarded a $1,956,704.00 firm fixed price definitive contract to Emerald Innovations, Inc., a for-profit company based in Cambridge, Massachusetts. The goal of this 30-month project is to develop an objective, quantitative, and user-friendly digital endpoint to assess nocturnal scratching in children with atopic dermatitis. This digital endpoint is intended to modernize product evaluation for atopic dermatitis treatments, as requested in the FDA's...
<p>The U.S. Food and Drug Administration (FDA) awarded a $2,877,105.96 Firm Fixed Price Delivery Order contract to High Performance Technologies Innovations, LLC, a for-profit organization, to obtain expertise to establish a prototype data architecture for the Center for Tobacco Products (CTP) scientific data. The contract is part of the FDA Scientific Computing Support major program and has an ultimate completion date of July 3, 2016. The contract was not set aside.</p>
The Food and Drug Administration (FDA) awarded a $248,553.46 firm fixed price contract to the Institute For Clinical Pharmacodynamics, Inc., a for-profit organization, to develop modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This contract was awarded under the FDA's Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. The BAA...