Helping translate new technologies into safe, effective medical countermeasures

Part 2 of an occasional series on the ways FDA helps prepare for and respond to public health emergencies

FDA’s Medical Countermeasures Initiative (MCMi) Regulatory Science Program is developing tools, standards, and approaches to help assess medical countermeasure (MCM) safety, efficacy, quality, and performance. Examples of our research—conducted by FDA, and with extramural partners—includes:   Drug development tools, such as nonclinical models and immune biomarkers In silico predictive models, such as organs-on-chips Next-generation sequencing-based in vitro diagnostic platforms Reference materials to support development of MCMs for threats such as Ebola and Zika

MCM Regulatory Science

Related information Regulatory science research tools (MCM-related regulatory science tools funded or partially funded by FDA) MCMi FY 2018 program update (PDF, 4 MB – see page 34 for regulatory science updates) FDA’s MCM roles, part 1: How FDA helps make MCMs available in emergencies (PDF, 106 KB) What are medical countermeasures?