The Food and Drug Administration awarded a $948,781 definitive contract to Digital Medicine Society Inc. on September 30, 2026, for modernizing outcome data for opioid use disorder under the FY26 FDA Broad Agency Announcement for Advanced Research and Development of Regulatory Science, with no set-aside used.
The originating BAA, posted November 21, 2025, and amended through January 16, 2026, seeks extramural research and development proposals to advance regulatory science across three primary charge areas: modernizing the development and evaluation of FDA-regulated products, strengthening post-market surveillance and labeling, and invigorating public health preparedness and response. The solicitation operates under FAR 6.102(d)(2) and 35.016 and encompasses research priority areas including new approach methodologies, advanced manufacturing, analytical and computational methods, biomarkers, clinical outcome assessments, and emerging technologies. Multiple awards were anticipated under the BAA with government discretion on funding availability.
Place of performance is Boston, MA. The contract is firm fixed price with a ceiling value of $948,781 and ultimate completion date of December 30, 2027. The opportunity is classified under NAICS 541714 (Research and Development in Biotechnology) and PSC code AJ11 (General Science and Technology R&D Services).