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 (ML) and/or artificial intelligence (AI) could help to identify post-market signals efficiently in an automated and repeatable fashion, facilitating timely regulatory action. The purpose of this funding opportunity is to develop and test an AI- or ML-based algorithmic RWD model for post-market surveillance of complex generic drug products.
Who can apply
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 statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).
What it funds
How to apply
Read the full announcement on Grants.gov before you start. Federal applications are submitted through Grants.gov (or the agency's own system) and require a Unique Entity ID from SAM.gov. Registration can take several weeks, so start early. Contact: Terrin Brown Grantor · terrin.brown@fda.hhs.gov · 2403387494
What are the odds for a first-time applicant?
A realistic target for an established nonprofit. 16% of awards go to first-time applicants and nonprofits win 20%. Based on 388 new awards in FY2023–25. The median award is $549,857. Expect about 70 days between posting and deadline.
Who can apply for 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?
Eligible applicants: Special district governments; For-profit organizations; Native American tribal organizations; 501(c)(3) nonprofits; Nonprofits without 501(c)(3) status; County governments; Unrestricted (open to anyone); Private colleges & universities; State governments; Independent school districts; Small businesses; City or township governments; Public & Indian housing authorities; Public & state-controlled colleges; Federally recognized tribal governments. 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
When is the deadline?
The funder has forecast this opportunity but hasn't announced a deadline yet. Sign up for a reminder and we'll email you when it opens.
How much funding is available?
Individual awards: Up to $300K. Expected number of awards: 1.
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