The goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure (MCM) safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective MCMs.
Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA). Learn more and view current projects.
FDA also funds MCM regulatory science through competitive intramural research grants.
Regulatory science research tools
FDA helps create tools needed to assess MCM safety, efficacy, quality and performance. View MCM-related regulatory science tools available to researchers.
Animal Rule information
The Animal Rule may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.