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  1. Medical Countermeasures Initiative (MCMi)

MCM Regulatory Science

The 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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BAA white papers due by January 21, 2022, 5:00 p.m., ET

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.

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Qualified 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.

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Attendees participate in a course presented by MCMi

MCMi regulatory science presentations

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

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