2021 FDA Science Forum
U.S. Food and Drug Administration’s Medical Countermeasures Initiative (MCMi) – Strengthening Regulatory Science to Further the Development of Medical Countermeasures
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Contributing OfficeOffice of the Commissioner
Abstract
In 2010, the U.S. Food and Drug Administration (FDA) established the Medical Countermeasures Initiative (MCMi) focusing increased resources on promoting the development of MCMs by establishing clear regulatory pathways for MCMs, instituting effective regulatory policies and mechanisms to facilitate timely access to available MCMs, and advancing MCM regulatory science to create the tools, standards, and approaches that support regulatory decision-making.
As such the FDA plays a vital and active role protecting the United States from chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats (such as SARS-CoV-2, Zika, and Ebola viruses, and pandemic influenza). The FDA is responsible for assessing the safety and effectiveness of MCMs – including diagnostic tests, drugs, and vaccines – that are needed to counter these threats. In addition, The FDA works closely with public and private sector partners to advance the development and availability of investigational MCMs.
The MCMi Regulatory Science Program has supported over 200 intra- and extramural regulatory science projects that have resulted in the development of innovative regulatory science tools and capabilities. Examples include support of SARS-CoV-2 and Zika virus reference reagents for diagnostic developers, FDA-ARGOS (a publicly available microbial genomic sequence reference database for diagnostic tests based on next generation sequencing technology), the cross-species immune reference database, and development of microphysiological systems models of COVID-19 and acute radiation syndrome to support MCM evaluation.
