MCMi is an FDA-wide initiative to coordinate medical countermeasure (MCM) development, preparedness, and response.
MCM legal, regulatory & policy framework
Helping ensure that U.S. laws, regulations and policies support preparedness and response for potential CBRN and emerging infectious disease threats.
MCM regulatory science
Developing the tools, standards, and approaches to assess MCM safety, efficacy, quality, and performance, and helping translate new technology into innovative, safe, and effective MCMs.
MCM-related emergency preparedness and response topics, including Ebola, antimicrobial resistance, smallpox, and pediatric MCMs.
MCMi professional development activities
Helping FDA meet the regulatory challenges posed by new science and technology developments.