Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
ID: 351128Type: Forecasted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$250K - $250K

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/351128
Timeline
    Description

    The Food and Drug Administration (FDA) is forecasting a funding opportunity for the identification of drug-related and formulation-related factors that lead to alcohol dose dumping (ADD) in modified release oral drug products through a cooperative agreement. The objective of this research is to develop tools that facilitate the creation of generic MR drug products with a low potential for ADD, support regulatory decision-making, and provide evidence for the FDA to refine its recommendations regarding ADD assessments. This initiative is crucial as modified release oral drug products pose significant risks when exposed to alcohol, potentially leading to severe health consequences. The funding amount is set at $250,000, with one award anticipated, and interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov or (240) 402-7610 for further information. The opportunity is part of the fiscal year 2024 and has no cost-sharing or matching requirements.

    Point(s) of Contact
    Terrin Brown Grantor
    (240) 402-7610
    terrin.brown@fda.hhs.gov
    Files
    No associated files provided.
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