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.
MCM emergency use authorities
FDA may need to use special authorities to allow the use of MCMs in impacted populations during or in anticipation of emergencies. More information about mechanisms FDA can use to allow the emergency use of MCMs, including EUA.
MCM-related counterterrorism legislation
Summary of federal legislation enacted to strengthen the nation's preparedness for responding to public health emergencies involving CBRN and emerging infectious disease threats.
State, tribal, local, and territorial public health preparedness
FDA works closely with stakeholders at the state and local levels to support public health preparedness and response efforts related to MCMs.
Guidance and other information of special interest to MCM stakeholders
Guidance documents of special interest to existing or prospective MCM sponsors, and other stakeholders, including state, tribal, local, and territorial public health preparedness personnel.
MCM-related cooperative arrangements
FDA and MCMi use a variety of cooperative arrangements to further development and availability of MCMs, including Confidentiality Commitments and Memoranda of Understanding.
MCM-related legal and policy presentations, publications and Q&As
Updates on FDA activities to support the MCM-related legal and policy framework, to better protect national health and security.