Closed · RFA-FD-24-007 · CFDA 93.103 · Discretionary

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

Federal grant opportunity posted by Food and Drug Administration, cataloged on Grants.gov.

up to $300K
Award range
Closed
Status
April 8, 2024
Close date
1
Expected awards

The verdict

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 is a closed discretionary listing from Food and Drug Administration that offered Up to $300,000 across 1 expected award. Future funding cycles may be published under the same CFDA number. PlainGrants indexes 481 other opportunities from Food and Drug Administration.

up to $300K
award range
Closed
application status
1
expected award
93.103
CFDA program

Archived opportunity record

Utilizing Real-World Data and Algorithmic Ana… is closed (last close April 8, 2024). The parent program page for CFDA 93.103 is the reliable place to catch re-announcements. Food and Drug Administration still indexes 481 other opportunities here.

According to Grants.gov (extract vintage 2026-08-10), this record reflects the officially published listing. See methodology.

Deadline tracker

Application window closed

Closed April 8, 2024

Posted Jan 15 Closes Apr 8

Est. Total Funding

$300,000

Expected Awards

1

Instrument

Cooperative Agreement

Description

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.

Wide-open applicant board · 15 Grants.gov doors

Utilizing Real-World Data and Algorithmic Ana… prints 15 distinct Grants.gov eligibility doors (State governments; County governments; City or township governments; Special district governments; +11 more). Filter fit before reading award size as demand — most applicant classes appear on the row. The extract does not mark applicant cost-sharing as required. Instrument: Cooperative Agreement. Funding-activity codes span Agriculture · Consumer Protection · Food and Nutrition (AG;CP;FN). Only 11 other Food and Drug Administration listings share this exact eligibility-code string (2% of 482).

Code 00
State governments
Code 01
County governments
Code 02
City or township governments
Code 04
Special district governments
Code 05
Independent school districts
Code 06
Public / state-controlled institutions of higher education
Code 07
Federally recognized tribal governments
Code 08
Public / Indian housing authorities
Code 11
Native American tribal organizations (other than Federally recognized tribal governments)
Code 12
Nonprofits with 501(c)(3) status (other than IHEs)
Code 13
Nonprofits without 501(c)(3) status (other than IHEs)
Code 20
Private institutions of higher education
Code 22
For-profit organizations other than small businesses
Code 23
Small businesses
Code 99
Unrestricted / see official listing

Codes are Grants.gov eligibility category values from the extract vintage 2026-08-10. Confirm the full eligibility statement on the official listing or the Grants.gov eligibility reference.

Official Listing on Grants.gov

View full details, application forms, and submission instructions.

View on Grants.gov

Agency Contact

Terrin Brown Grantor

What to do next

Utilizing Real-World Data and Algorithmic Ana… is closed; use the parent program and agency catalog for the next funding cycle.

  • Parent CFDA 93.103 may publish future NOFOs under the same assistance listing. Open program
  • Food and Drug Administration Research indexes 42 Grants.gov listings in this extract. Program profile
  • Food and Drug Administration lists 481 other indexed opportunities on PlainGrants. Agency catalog

Opportunity deadlines and eligibility change on Grants.gov; PlainGrants mirrors the extract and is not the submission system.

Disclaimer: This information is sourced from Grants.gov and SAM.gov and is for informational purposes only. Opportunity details, deadlines, and eligibility requirements change frequently. Always verify current information directly on Grants.gov before applying. PlainGrants is not affiliated with any federal agency.

Data sourced from the SAM.gov Assistance Listings and Grants.gov. See our methodology for details. Retrieved and formatted by PlainGrants