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 novel coronavirus (2019-nCoV), Ebola, antimicrobial resistance, smallpox, and pediatric MCMs.
MCMi professional development activities
Training courses and activities to help FDA meet the regulatory challenges posed by new science and technology developments.
An FDA-wide initiative to coordinate MCM development, preparedness and response.
MCMi news and events
MCM and public health emergency news and events from FDA and partners.
MCMi program update
Report: FDA approved 28 MCMs in fiscal year 2018. Learn more about how we're protecting national health and security.