Emergency Preparedness and Response
MCM Regulatory Science
The goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective medical countermeasures (MCMs).
To highlight progress of ongoing regulatory science research, and discuss the future of MCM regulatory science, FDA hosts an annual MCMi Regulatory Science Symposium.
MCMi also works with FDA medical product centers to facilitate guidance and regulatory science to support the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.