The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the development of regulated therapeutic and diagnostic solutions for patients affected by Opioid and/or Stimulants use Disorders (OUD/StUD). The current drug crisis involving opioids and stimulants has resulted in a significant number of deaths and a need for comprehensive solutions. This funding opportunity aims to support research and development activities for novel medical products that address the needs of patients suffering from OUD/StUD. The two areas of focus for this solicitation are pharmacotherapeutics (small molecules and biologics) and medical therapeutic and diagnostic devices, including software as a medical device. The research topics may include the development of new medications, longer-acting formulations, advanced drug delivery systems, biomarkers, imaging technologies, therapeutic devices, in vitro diagnostic assays, and digital therapeutics. The projects proposed under this solicitation may fall under Phase I, Phase II, Fast Track, or Direct to Phase II categories. The funding opportunity is open until February 15, 2025. For more information and to apply, visit the grants.gov website or the National Institutes of Health's solicitation agency URL.