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        Medical Countermeasures Initiative (MCMi)

MCM Regulatory Science

                        
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          Extramural Research
          Intramural Research
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          Medical Countermeasures Initiative (MCMi)
          MCM Regulatory ScienceMedical Countermeasures Initiative (MCMi) MCM Regulatory Science
  	
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    PrintThe goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure (MCM) safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective MCMs.
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          In this sectionPhoto montage of clipart that includes a microscope, viles, and test tubes

                    Extramural research
            Extramural MCM regulatory science is primarily funded through a Broad Agency Announcement (BAA). Learn more and view current projects.
          
          FDA scientist Anjuli Jain conducts an experiment validating nonclinical biomarker models for traumatic brain injury in Dr. Welle’s lab. This research will potentially help establish a regulatory pathway for the use of emerging flexible EEG technologies to rapidly detect brain injury during emergency response situations, such as explosions.
      

            
      FDA scientist Anjuli Jain conducts an experiment validating nonclinical biomarker models for traumatic brain injury. This research could help establish a regulatory pathway for flexible EEG technologies to rapidly detect brain injury during emergencies.

                    Intramural research
            FDA also funds MCM regulatory science through competitive intramural research grants.
          More in this sectionQualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)
      

            
      Qualified Zika test manufacturers can request an FDA reference panel to determine if their tests can differentiate flaviviridae antibodies (Zika, dengue, or West Nile)

                    Regulatory science research tools
            FDA helps create tools needed to assess MCM safety, efficacy, quality and performance. View MCM-related regulatory science tools available to researchers.
          
          Gloved hand of FDA scientist working with lab equipment at FDA headquarters in White Oak, Maryland

                    Animal Rule information
            The Animal Rule may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.
          More in this sectionphoto of a microphone against a blurry background

                    MCMi regulatory science presentations
            Archive of event materials related to MCM regulatory science, presented by FDA staff.

                                                                                  Content current as of:
      03/13/2023
                  
                   
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			  Research
				    				       				    				       Laboratory Methods
				       				    				       Toxicology
				       				    				       Biotechnology
				       				    				       EmergenciesMCM Regulatory Science                
                          

                        Animal Rule Information
          Extramural Research
          Intramural Research
          MCMi Regulatory Science Presentations
          Regulatory Science Research Tools
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