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
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 is offered by Food and Drug Administration. Max award: $300,000. This is a forecast; the deadline is not set yet.
| Opportunity number | FOR-FD-24-003 |
|---|---|
| Agency | Food and Drug Administration |
| Status | Forecasted |
| Posted | Nov 24, 2023 |
| Closes | Not set |
| Award ceiling | $300,000 |
| Award floor | $300,000 |
| Total program funding | Not specified |
| Expected awards | 1 |
| Who can apply | Native American tribal organizations (other than Federally recognized tribal governments), Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility", City or township governments, Independent school districts, Special district governments, Small businesses, State governments, For profit organizations other than small businesses, Native American tribal governments (Federally recognized), Private institutions of higher education, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Public and State controlled institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, County governments, Public housing authorities/Indian housing authorities |
| Category | Agriculture, Consumer Protection, Food and Nutrition |
Summary (excerpt)
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-…
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