The approval or clearance of drugs, biologics, devices, and diagnostics can be a time-consuming and expensive process, and advancing medical countermeasures (MCMs) against chemical, biological, radiological, and nuclear agents (CBRN) through the regulatory process results in unique challenges.  Depending on the threat, there may be a paucity (or complete absence) of human cases in which a countermeasure might be evaluated; alternatively cases may be relatively abundant but in locations inaccessible to standard clinical trials.   New assays or diagnostics may need to be developed for emerging infectious diseases, and biomarkers and/or animal models might be in very early stages of development.  Reacting to the regulatory science knowledge gaps, in 2010 the FDA launched the Medical Countermeasures Initiative (MCMi) to foster the development and availability of medical countermeasures (MCMs).  The MCMi strives to ensure that FDA has the tools, standards, and approaches necessary to assess MCM safety, efficacy, quality, and performance, and to help translate cutting-edge science and technology into approved products. This presentation will present an overview of the MCMi program and highlight specific projects that have helped mitigate CBRN regulatory science challenges facing FDA. <br/>

Challenges to the development of countermeasures to chemical and biological warfare agents

251st National Meeting (2016)

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