Cooperative Agreement U01FD008654
- This Cooperative Agreement award from the Food and Drug Administration (FDA) Research program (CFDA 93.103) provides $249,826 in funding to The Critical Path Institute (C-Path) to complete psychometric analyses and develop a quantitative study report to support the qualification of the Chronic Heart Failure Symptom Scale (CHF-SS) as a fit-for-purpose clinical outcome assessment for regulatory decision-making in heart failure drug development. The project involves three main aims: 1) finalizing...
- This Project Grant award of $150,000 from the Food and Drug Administration (FDA) Research program (CFDA 93.103) supports the Critical Path Institute's (C-Path) 4-day "C-PATH Global Impact Conference". The conference will showcase the work of several C-Path public-private partnerships (PPPs) in developing solutions to accelerate drug development, particularly in the areas of neurology, rare/orphan conditions, and pediatrics. It will bring together diverse stakeholders, including...
- This federal Cooperative Agreement award from the Food and Drug Administration (FDA) under CFDA program 93.103 (FDA Research) provides $249,984 to The Critical Path Institute (C-Path) to develop a Qualification Plan (QP) to support the qualification of the Virtual Reality Functional Capacity Assessment Tool-Short List (VRFCAT-SLX) as a performance outcome measure of cognition-dependent daily functioning for individuals with biomarker-positive, clinical stage 2 and 3 Alzheimer's disease. The...
- This federal Project Grant award from the National Institute of Nursing Research (NINR) under CFDA 93.361 - Nursing Research, will support the development and evaluation of IMAAP, an interactive mobile asthma action plan. The $441,375 award, effective July 17, 2024 through May 31, 2026, aims to create an innovative technology that leverages objective lung function assessment, symptom reporting, and personalized treatment recommendations to empower adolescents, particularly those from...
- This Cooperative Agreement awarded by the Food and Drug Administration (FDA) under the FDA Research program (CFDA 93.103) provides $249,580.00 to support the Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center in conducting a series of studies to establish the analytic validity of non-calcified plaque volume (NCPV) measured by coronary CT angiography (CCTA) as a prognostic biomarker for coronary artery disease. The key objectives are to standardize the precision,...
- The U.S. Food and Drug Administration (FDA), through the FDA Research program (CFDA 93.103), awarded a $250,000 Cooperative Agreement to Yale University to develop a comprehensive qualification package for the Positive Symptoms and Diagnostic Criteria for the Comprehensive Assessment of At-Risk Mental States (PSYCHS) clinical outcome assessment instrument. The PSYCHS is designed to measure the severity of attenuated psychosis syndrome, a mental health condition affecting approximately 1.7% of...
- This Cooperative Agreement award from the U.S. Food and Drug Administration (FDA), under the FDA Research program (CFDA 93.103), provides $245,356 to Perspectum, Inc. to conduct a retrospective, multi-center longitudinal observational study. The study aims to collect and analyze magnetic resonance cholangiopancreatography (MRCP) data to generate 3D models and associated MRCP+ metrics, specifically focused on the MRCP+ metric "number of strictures." The goal is to determine how...
- This Project Grant award from the National Heart, Lung, and Blood Institute (CFDA 93.837 Cardiovascular Diseases Research) provides $771,750 to the Albert Einstein College of Medicine to conduct a cluster randomized controlled trial called "PRAGMATIC-S". The project aims to create an innovative interface between primary care and school-based programs to optimize the delivery of guideline-based asthma care to urban children with persistent or uncontrolled asthma. The award period runs...
- This Cooperative Agreement award from the Food and Drug Administration (FDA) under the Food and Drug Administration Research program (CFDA 93.103) provides $150,000 in funding to the Pharmaceutical Inspection Co-Operation Scheme-Association De Droit Suisse to develop curricula and training tools for a web-based educational center called the PIC/S Inspectorates' Academy (PIA). The goal is to harmonize and standardize Good Manufacturing Practice (GMP) training and qualification processes for...
- The federal Project Grant award of $156,899.00 from the National Heart, Lung, and Blood Institute (CFDA 93.837 - Cardiovascular Diseases Research) supports research to identify distinct clinical phenotypes of pediatric status asthmaticus and evaluate the effects of adjunctive asthma treatments like magnesium and aminophylline across those phenotypes. The primary awardee, Trustees of Indiana University - Indianapolis, will conduct this research over a period from July 2025 to June 2030. The...
This Cooperative Agreement award from the Food and Drug Administration (FDA) Research program (CFDA 93.103) is for $250,000.00 to support the Critical Path Institute (C-Path) in conducting psychometric analyses and generating a quantitative study report to qualify the Pediatric Asthma Diary-Child (PAD-C) and Pediatric Asthma Diary-Observer (PAD-O) measures. These clinical outcome assessment tools are intended to evaluate the severity of asthma symptoms and signs in children under 12 years old to support endpoints in pediatric asthma clinical trials. The award period runs from Sep 1, 2025 to Aug 31, 2026 and aligns with the FDA's Center for Drug Evaluation and Research's initiative to qualify these patient-focused measurement approaches through rigorous development and validation.
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $250.0k | 9/10/25 |