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U.S. Department of Health and Human Services

Emergency Preparedness and Response

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MCM Legal, Regulatory and Policy Framework

Montage of Pillar 3 highlighted, gavel and lab beaker, pills spilling from bottle


FDA Medical Countermeasures Initiative efforts to modernize the legal, regulatory, and policy framework for an effective public helath response support medical countermeasure (MCM) Action Teams and regulatory science efforts by ensuring that U.S. laws, regulations, and policies enable the application of advances in regulatory science to the regulatory review process and adequately support U.S. preparedness for and response to CBRN agents and emerging infectious disease threats with MCMs.

To do so, FDA is assessing the strengths and weaknesses of the current legal, regulatory, and policy environment regarding MCM development, distribution, administration, and use. Where changes are needed to better protect public health, FDA is working with appropriate partners to develop and propose new approaches.


2012-2013 Pillar III Highlights (legal, regulatory and policy framework)