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
ID: 351125Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$300K - $300K

Eligible Applicants

Unrestricted

Funding Category

Consumer Protection

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351125
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a funding opportunity titled "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)." This initiative aims to develop and test an AI- or ML-based algorithmic model utilizing real-world data to enhance post-market surveillance of complex generic drug products, addressing the need for effective monitoring of therapeutic equivalence and regulatory decision-making. The funding opportunity is significant as complex generic drugs are increasingly prevalent in the marketplace, necessitating modernized surveillance approaches to ensure patient safety and efficacy. Interested applicants can apply for a cooperative agreement with an award ceiling and floor of $300,000, and should direct inquiries to Terrin Brown at terrin.brown@fda.hhs.gov or by phone at 240-338-7494. The opportunity is open to unrestricted applicants, with the fiscal year 2024 as the target for funding.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 338-7494
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
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