Medical Countermeasures Initiative (MCMi)
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 COVID-19, mpox, Ebola, antimicrobial resistance, smallpox, pediatric MCMs, and more.
MCMi professional development activities
Training courses and activities to help FDA meet the regulatory challenges posed by new science and technology developments.
MCMi news and info
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
Learn more about how FDA works every day to protect national health and security, and support public health emergency preparedness.
COVID-19 updates from FDA
The latest COVID-19 news from FDA, plus frequently asked questions and resources for consumers, health care providers, medical product sponsors, and other stakeholders.
Emergency Use Authorization (EUA)
Expiration Dating Extension
What are Medical Countermeasures?
Advanced Manufacturing for Public Health Emergency Preparedness and Response
Assistant Commissioner for Counterterrorism Policy, and Director, OCET