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
- Opening date not announced
- Award size
- Up to $300K
- Match ?
- Not required · Work out your budget and match
- Who can apply
- Tribal organization, Special district (utility, fire, etc.), Larger business, Anyone (unrestricted), School district, Tribal government, County government, 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), and others named in the official notice
- Where
- Anywhere in the U.S., including Tennessee
Opening soon: the funder has announced this grant, but you can't apply yet. Use the time to get ready and check whether it fits.
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. Get-ready checklist
How this fits you
- Available in Rhea County (nationwide program)
- No match required
- Past Tennessee awards on file: 42
Tell us who you are to see whether you're eligible.
Official notice: https://simpler.grants.gov/opportunity/72e1732b-ce47-49a4-98c0-8c04576cceff · Printed from grantme.click/grants/a08c3f05-2dae-475d-83f4-14b447584d7d
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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, from the official 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).
Writing the need statement? Rhea County facts with citations.
Who in Tennessee has won this program
20 awards to Tennessee groups in 5 counties since 2016 · 0 in Rhea County. Largest shown:
| Past winner | Where | Amount | Fiscal year |
|---|---|---|---|
| University of Tennessee | Knoxville, Knox County | $6.5M | 2020 |
| State of Tennessee | Nashville | $2.7M spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $2.5M | 2019 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $2.4M | 2020 |
| University of Tennessee | Memphis, Shelby County | $2M | 2017 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.9M | 2020 |
| University of Tennessee | Knoxville, Knox County | $1.8M | 2025 |
| Franklin Special School District | Franklin, Williamson County | $1.8M | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | $1.6M | 2022 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2021 |
| Tennessee Department of Health | Nashville, Davidson County | $1.3M | 2020 |
| Tennessee Department of Agriculture | Nashville, Davidson County | $1.3M | 2016 |
Source: USAspending.gov, Federal Audit Clearinghouse. Past awards show who this program funds. They don't guarantee future awards.
Tennessee groups that got this money through a state agency or another organization
This federal money also reaches local groups as pass-through grants. 22 pass-through grants on file · 0 in Rhea County. Largest shown:
| Past winner | Where | Through | Amount | Fiscal year |
|---|---|---|---|---|
| Combinedbrain, Inc | Brentwood | Duke University | $538K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Harvard Pilgrim Health Care | $241K spent that year | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $75K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Regents of the University of California, San Francisco, the | $69K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic Hospital | $51K spent that year | 2025 |
| Volumetrix Inc. | Nashville, Davidson County | The Children's Hospital of Philadelphia | $50K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2023 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Mayo Clinic | $43K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | Cumberland Pharmaceuticals Inc | $42K spent that year | 2025 |
| Loch & Key Productions, LLC | Knoxville, Knox County | Association of Public Health Laboratories, Inc. (THE) | $33K | 2025 |
| Vanderbilt University Medical Center | Nashville, Davidson County | The Queen's Medical Center | $32K | 2024 |
| Vanderbilt University Medical Center | Nashville, Davidson County | University of California-San Francisco | $29K spent that year | 2025 |
Source: USAspending.gov pass-through reports (the first recipient reports each one of $30,000 or more).
About the federal program
Food and Drug Administration Research, also called “General Grant Funding”
Program number 93.103 (the federal Assistance Listing number) · U.S. Department of Health and Human Services, Food and Drug Administration · Cooperative agreement (a grant with close agency involvement), project grant
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.
Match
None required (federal program listing).