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 In this section:

        Counterterrorism and Emerging Threats

Medical Countermeasures Initiative (MCMi)

                        
                


                About MCMi
          MCM Issues
          Medical Countermeasures Initiative Collaborations
          MCM Regulatory Science
          MCM Legal, Regulatory and Policy Framework
          MCMi Professional Development Activities Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)Counterterrorism and Emerging Threats Medical Countermeasures Initiative (MCMi)
  	
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    PrintMCMi is an FDA-wide initiative to coordinate medical countermeasure (MCM) development, preparedness, and response.
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          MCMi activitiesGavel and stethoscope, representing medical countermeasure-related counterterrorism legislation

                    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.
          
          FDA scientist dividing plasma from individuals recently infected with dengue or West Nile viruses into smaller volume samples for distribution. These samples were part of a reference panel FDA created for qualified Zika test manufacturers, to determine if their tests can differentiate flaviviridae antibodies—that is, if the test can accurately show if a person was infected with Zika, dengue or West Nile, as antibodies for these viruses are very similar.

                    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.
    
          Hospital emergency staff, representing public health emergency-related issues

                    MCM issues
            MCM-related emergency preparedness and response topics, including COVID-19, mpox, Ebola, antimicrobial resistance, smallpox, pediatric MCMs, and more.
    
          Photo montage of students learning in a mock BSL-4 lab with and without BSL hazmat suits on.
      

            
      Attendees at this annual training focus on the preparation and execution of research clinical trials to facilitate the approval of medical countermeasures for high-consequence pathogens.

                    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 infoGavel and test tubes, representing regulatory and scientific components of the Medical Countermeasures Initiative

                    About MCMi
            An FDA-wide initiative to coordinate MCM development, preparedness, and response.
          
          News & events text shown on typewriter

                    MCMi news and events
            MCM and public health emergency news and events from FDA and partners.
    
          MCMi Program Update report cover - FY 2022

                    MCMi program update
            Learn more about how FDA works every day to protect national health and security, and support public health emergency preparedness.
    
          6 photos: FDA Commissioned Corps officers donning protecting gowns, gloves, masks and visors; 3D illustration of the coronavirus; cotton facemask; physician wearing medical gloves drawing vaccine or antiviral drug from vial with a syringe; closeup of blood in beaker labeled COVID-19 Positive; closeup of scientist preparing to examine sample under microscope

                    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.
          Popular LinksEmergency sign

                    Emergency Use Authorization (EUA)
          
          Pharmacist checking medicine boxes on a shelf, representing expiration date extension. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability.
      

            
      Pharmacist checking medicine boxes on a shelf, representing expiration date extension. In some cases, testing has shown that certain properly stored medical products can be used beyond their labeled expiration date if they retain their stability.

                    Expiration Dating Extension
    
          Examples of MCMs include drugs, vaccines, and devices, such as diagnostic tests and personal protective equipment.
      

            
      Examples of MCMs include drugs, vaccines, and devices, such as diagnostic tests and personal protective equipment.

                    What are Medical Countermeasures?
    
          Robot arm and human hand meet, with gears, representing the concept of advanced manufacturing

                    Advanced Manufacturing for Public Health Emergency Preparedness and Response
          More info for stakeholdersGuidance and other information of special interest to MCM stakeholders21st Century Cures Act: MCM-related Cures provisions, including MCM PRVsExecutive Order 13944 List of Essential Medicines, MCMs & Critical InputsFAQs: What happens to EUAs when a public health emergency ends?
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              Contact Us
        
      
  Contact Point
              Michael Mair, MPH
Assistant Commissioner for Counterterrorism Policy, and Director, OCET
      
	AskMCMi@fda.hhs.gov
      
	
	
		www.fda.gov/medicalcountermeasures
    Twitter: @FDA_MCMi
              
	
	Hours Available

	
		Office of Counterterrorism and Emerging Threats

                                                                                  Content current as of:
      04/24/2023
                  
                   
Topic(s)
			  Emergency ResponseMedical Countermeasures Initiative (MCMi)                
                          

                        


                        About MCMi
          MCM Issues
          MCMi Collaborations
          MCM Regulatory Science
          MCM Legal, Regulatory and Policy Framework
          MCMi Professional Development Activities
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