[Food and Drug Administration](https://www.fda.gov/)

Forecasted (official due date not yet posted)

$300,000 (single award; cooperative agreement)

Supports development and testing of AI/ML models using real-world data to monitor clinical outcomes in patients switching between complex generic and reference drugs.

Clinical trials are not allowed; opportunity is currently forecasted, not open.

--- ## Description This funding opportunity from the FDA aims to modernize post-market surveillance of complex generic drug products by leveraging real-world data (RWD) and advanced algorithmic analyses. The goal is to develop and test artificial intelligence (AI) or machine learning (ML) models that can efficiently and automatically identify clinical outcome signals when patients switch between therapeutically equivalent complex generics and their reference listed drugs (RLDs). The results are intended to inform regulatory decision-making and ensure ongoing therapeutic equivalence in the marketplace. Complex generics often have unique user interface characteristics compared to their brand-name counterparts, which may impact patient outcomes. This initiative seeks to address the need for robust, automated post-market monitoring tools that can detect potential issues in a timely and repeatable manner. --- ## Due Dates - **Forecasted:** The opportunity is currently in the forecast stage; an official application due date has not yet been posted. - Researchers should monitor [Grants.gov](https://www.grants.gov/search-results-detail/351125) for updates. --- ## Funding Amount - **Total Funding:** $300,000 - **Award Type:** Cooperative Agreement - **Expected Number of Awards:** 1 - **Award Ceiling/Floor:** $300,000 (single award) - **Cost Sharing/Matching:** Not required --- ## Eligibility Eligible applicants include: - State, county, city, or township governments - Special district governments - Independent school districts - Public and state-controlled institutions of higher education - Private institutions of higher education - Native American tribal governments (federally recognized and other) - Public housing authorities/Indian housing authorities - Nonprofits with or without 501(c)(3) status (excluding higher education institutions) - For-profit organizations (including small businesses) - Unrestricted (open to any type of entity listed above) **Additional Notes:** - Organizations may submit more than one application if each is scientifically distinct. - Duplicate or highly overlapping applications will not be accepted for review at the same time. --- ## Application Process - The opportunity is currently forecasted; application instructions will be available once the official notice is posted. - Applications will be submitted via [Grants.gov](https://www.grants.gov/search-results-detail/351125). - Monitor the [official opportunity page](https://www.grants.gov/search-results-detail/351125) for updates on the application package and deadlines. --- ## Additional Information - **Clinical trials are not allowed** under this opportunity. - The project is intended to advance regulatory science by improving post-market surveillance methodologies for complex generics. - The funding instrument is a cooperative agreement, indicating substantial involvement by the FDA in project activities. --- ## External Links - [FDA Funder Page](https://www.fda.gov/) - [Official Grants.gov Opportunity Listing](https://www.grants.gov/search-results-detail/351125) - [FDA Contact Page](https://www.fda.gov/about-fda/contact-fda) --- ## Contact Information | Name | Role | Email | Phone | |--------------|---------|---------------------------------------|---------------| | Terrin Brown | Grantor | [terrin.brown@fda.hhs.gov](mailto:terrin.brown@fda.hhs.gov) | 240-338-7494 | | FDA General | | [patientaffairs@fda.hhs.gov](mailto:patientaffairs@fda.hhs.gov) | (888)-463-6332 |

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

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