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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCM Regulatory Science

 

FDA scientist adjusting equipment in lab at FDA headquarters at White Oak, MDThe goal of the Medical Countermeasures Initiative (MCMi) regulatory science program is to develop the tools, standards, and approaches to assess medical countermeasure safety, efficacy, quality, and performance and to help translate cutting-edge science and technology into innovative, safe, and effective medical countermeasures (MCMs).

 

FDA funds MCM regulatory science through intramural and extramural research grants, and forms scientific partnerships that help develop solutions to complex regulatory science challenges.

 

To highlight progress of ongoing regulatory science research, and discuss the future of MCM regulatory science, FDA hosts an annual MCMi Regulatory Science Symposium.

 

MCMi also works with FDA medical product centers to facilitate guidance and regulatory science to support the Animal Rule, which may be used to grant marketing approval of certain products when human challenge studies would not be ethical or feasible.

 

Read more about regulatory science and medical countermeasures in the FDA Voice Blog.