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
View forecast on Grants.gov →Forecasted — not yet open · no update since it was posted
- Posted
- November 24, 2023
- Closes
- See announcement
- Award ceiling
- $300,000
- Award floor
- $300,000
- Expected awards
- 1
- Cost sharing
- No
- Instrument
- Cooperative Agreement
- Assistance listing
- 93.103
- Category
- Agriculture, Consumer Protection, Food and Nutrition
Program funding history
Awards made under Assistance Listing 93.103 across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- $213M
- FY2026 obligated
- $215.3M
- FY2027 (to date) obligated
- $0
- Awards in window
- 849
Top recipients: The Critical Path Institute, National Environmental Health Association, Association of Food & Drug Officials, Yale Univ, Food & Agriculture, California Department of
Source: USAspending.gov · refreshed October 2026 · Program page: awards, recipients and the opportunities under this listing →
Synopsis
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
- Public and State controlled institutions of higher education
- Native American tribal organizations (other than Federally recognized tribal governments)
- County governments
- City or township governments
- Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled "Additional Information on Eligibility"
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Small businesses
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- Special district governments
- Public housing authorities/Indian housing authorities
- For profit organizations other than small businesses
- State governments
- Independent school districts
- Private institutions of higher education
- Native American tribal governments (Federally recognized)
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).
How to apply
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