The U.S. Food and Drug Administration (FDA) is offering funding through the Drug Development Tools Research Grants (U01) Clinical Trials Optional, aimed at supporting research focused on Drug Development Tools (DDTs) that have an accepted or reviewable Letter of Intent within the qualification programs at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). The grants are intended to address significant gaps in drug development by facilitating the qualification of methods, materials, or measures designed to expedite the process, ultimately enhancing public health outcomes. Eligible applicants include higher education institutions, nonprofits, for-profit organizations, and government entities, with a funding ceiling of $500,000 per project over one or two years. Interested parties must submit their applications by May 13, 2024, or May 13, 2025, and can contact Terrin Brown at terrin.brown@fda.hhs.gov for further information.