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  1. Counterterrorism and Emerging Threats

MCM Legal, Regulatory and Policy Framework

MCM Legal, Regulatory and Policy Framework

The FDA Medical Countermeasures Initiative (MCMi) legal, regulatory, and policy framework ensures that U.S. laws, regulations and policies help support preparedness and response for potential chemical, biological, radiological, nuclear (CBRN) and emerging infectious disease threats.  We work with appropriate partners to assess how FDA can help MCM-related development, distribution, administration, post-administration assessment efforts, and where changes are needed to better protect public health, we develop and propose new approaches.


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Emergency Use Authorization (EUA)

The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

Expiration Dating Extension

Information on various expiration dating extension activities, including the Shelf Life Extension Program (SLEP), emergency use authorities and enforcement discretion.

EUA information for in vitro devices (IVDs)

How to Submit a Pre-EUA for In vitro Diagnostics to FDA

Pre-EUA information for manufacturers of IVD tests. A Pre-EUA package contains data and information about the safety, quality, and efficacy of the product, its intended use under a future or current EUA, and information about the emergency or potential emergency.


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