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

Summary

The Food and Drug Administration (FDA) is seeking research to identify drug-related and formulation-related factors that contribute to alcohol dose dumping of modified release oral drug products. This is a U01 cooperative research agreement mechanism, meaning FDA will have substantial scientific/programmatic involvement. Clinical trials are explicitly not allowed under this funding opportunity. The opportunity was posted as a forecast as of November 2023, meaning a formal solicitation had not yet been issued.

What they want

How they evaluate

Risks & flags

• Forecasted status only — no formal solicitation issued yet; limited detail available to assess competitiveness
• U01 mechanism implies FDA co-investigator involvement, which may favor applicants with pre-existing FDA research relationships
• No response deadline, value, or evaluation criteria disclosed — insufficient information to fully assess opportunity