Open Federal Grants · Food and Drug Administration
Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical
Food and Drug Administration · Opportunity FOR-FD-24-003 · Awards up to $300,000
Eligibility
Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The FDA will not accept duplicate or highly overlapping applications under review at the same time per 2.3.7.4 Submissi
Eligibility text quoted from the official Grants.gov listing.
About This Opportunity
Complex generic drug products represent an increasing share of the generic marketplace and may have distinct user interface differences compared to reference listed drug (RLD) products. A modernized post-market surveillance approach is needed to compare clinical outcomes between complex generic products and their corresponding RLD products to monitor for potential issues with therapeutic equivalence and to inform regulatory decision making. Real-world data (RWD) combined with machine learning (M …
Description from the official Grants.gov listing — read the complete notice, including any updates, on Grants.gov before applying.
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