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 Trial Not Allowed
This grant opportunity is focused on developing and testing an AI or ML-based model using real-world data for post-market surveillance of complex generic drug products. The aim is to efficiently identify and monitor any issues related to the therapeutic equivalence with their reference listed drug products. The project intends to enhance regulatory decision-making by providing a modernized app…
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 ge…
Funding Source
Awards & funding
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 Submission of Resubmission Application. This means that the NIH…
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