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

About this grant

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 Grant Number: FOR-FD-24-003. Expected awards: 1.

Eligibility requirements

All of the following criteria must be met:

• 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 or FDA will not accept:•A new (A0) application that is submitted before issuance of the summary statemen
• Grant Number: FOR-FD-24-003

What the funding covers

• Award Range: $3,00,000 to $3,00,000
• Expected Number of Awards: 1

How to apply

1. 1Applications must be submitted through grants.gov
2. 2Grant Number: FOR-FD-24-003
3. 3Posted: 2023-11-24

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