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
Food and Drug Administration
Description
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 approach to monitor these products' clinical outcomes.
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…
Source
Grant ID
FOR-FD-24-003
Funding Source
Food and Drug Administration
Eligibility
The following categories of applicants are invited to apply:
- For profit organizations other than small businesses
- County governments
- City or township governments
- Independent school districts
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Public housing authorities/Indian housing authorities
- Public and State controlled institutions of higher education
- State governments
- Small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal governments (Federally recognized)
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Special district governments
- Private institutions of higher education
Awards & Funding
Award Ceiling
$300,000
Award Floor
$300,000
Funding Amount
Discretionary
Links
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