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: 351808Type: Posted
Overview

Buyer

Food and Drug Administration (HHS-FDA)

Award Range

$0 - $250K

Eligible Applicants

Unrestricted

Funding Category

Food and Nutrition

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/351808

Additional Information

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-24-010.html
Timeline
    Description

    The U.S. Food and Drug Administration (FDA) is offering a funding opportunity (NOFO RFA-FD-24-010) aimed at identifying drug-related and formulation-related factors that contribute to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. The objective of this initiative is to develop tools that minimize the potential for ADD, thereby supporting regulatory assessments and enhancing the safety of generic medications. This research is crucial as it addresses the health risks associated with the rapid release of drugs when exposed to alcohol, which can lead to severe side effects. Funding of up to $250,000 is available for one year, with applications due by April 8, 2024. Interested applicants can reach out to Terrin Brown at terrin.brown@fda.hhs.gov for further information.

    Point(s) of Contact
    terrin.brown@fda.hhs.gov
    Files
    Title
    Posted
    RFA-FD-24-010.html
    The U.S. Food and Drug Administration (FDA) is offering a funding opportunity (NOFO RFA-FD-24-010) aimed at identifying factors that lead to alcohol dose dumping (ADD) in modified-release (MR) oral drug products. The proposed research seeks to develop tools that reduce the potential for ADD, thus supporting regulatory assessments and enhancing public access to safe, effective generic medications. The project specifically addresses formulation and drug-related aspects of ADD, emphasizing the importance of understanding how alcohol affects the release of drugs that may pose health risks. Key activities include evaluating various formulation designs, identifying drug attributes, and conducting in vitro assessments using different alcohol concentrations. Funding of up to $250,000 for one year is available, with a potential extension depending on performance. Eligible applicants include higher education institutions, nonprofits, and government entities, with application deadlines set for March 31, 2024. Overall, this initiative seeks to harmonize ADD assessment practices, improving drug safety and mitigating public health risks associated with alcohol consumption.
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