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 opportunity would fund teams to develop and test an AI/ML-based real-world data model for post-market surveillance of complex generic drug products. The goal is to compare patient clinical outcomes between complex generics and their corresponding reference listed drugs, helping regulators detect potential therapeutic equivalence issues efficiently. Note: this is labeled “Clinical Trial No…
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