Food and Drug Administration · Department of Health and Human Services
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
Key facts
- Deadline
- Forecast — no date yet
- Award size
- Up to $300K
- Cost share / match
- Not required
- Who can apply
- Tribal organization, Special district (utility, fire, etc.), Larger business, Anyone (unrestricted), School district, Tribal government, County government, Other (see eligibility), State government, Private college or university, City or town government, Small business, Nonprofit with 501(c)(3), Public college or university, Nonprofit without 501(c)(3)
- Where
- Anywhere in the U.S., including Tennessee
Before you apply: federal grants require an active SAM.gov registration (Unique Entity ID) and a Grants.gov account. Registration is free but can take weeks, so start now, not when the deadline is close. Grant-ready checklist
How this fits you
- Available in Tennessee (nationwide program)
- No cost share required
- Tennessee recipients since 2023: 18
Tell us who you are to see whether you're eligible.
Read the official notice View on Grants.gov
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.
Eligibility (from the notice)
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).
Who in Tennessee has won this program
18 awards to Tennessee recipients in 5 counties since federal FY2023. Largest shown:
| Recipient | Where | Amount | FY |
|---|---|---|---|
| University Of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $2.4M | 2020 |
| University Of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.9M | 2020 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| University Of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department Of Health | Nashville, Davidson County | $1.3M | 2020 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.3M | 2016 |
| Department Of Agriculture Tennessee | Nashville, Davidson County | $1.2M | 2025 |
Source: USAspending.gov. Past awards show who this program funds; they don't guarantee future awards.
About the program (93.103)
Food and Drug Administration Research — General Grant Funding
How applications are judged
Applicants should review the individual Funding Opportunity Announcement (FOA) issued under this CFDA program to see the specific evaluation criteria that applies.
Matching requirements
This program has no statutory formula.
Matching requirements are not applicable to this assistance listing.
MOE requirements are not applicable to this assistance listing.
Examples of funded projects
Not Applicable.