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Electronic health records are an important part of post-dispensing medical countermeasure monitoring and assessment

Background | FDA Guidance & Regulatory Information | Contact | FDA MCM Monitoring & Assessment Projects | Medical Product Assessment in General | Additional Resources

Background

There is a critical need for the U.S. Government (USG) to build and maintain a national capability to monitor and assess medical countermeasures (MCMs) after they are dispensed or administered in response to a chemical, biological, radiological, or nuclear threat or an emerging infectious disease.  In collaboration with the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), FDA has been a key partner in developing such a capability.

Historically, research as part of a public health emergency response has been limited. However, that is changing. Experiences responding to public health emergencies highlight the need for a coordinated plan to leverage every opportunity to learn more about an MCM’s performance.  This information is vital to protecting public health, particularly in the case of MCMs that may have limited human efficacy data prior to their use.  The emergency may present the only opportunity for clinical assessment.

The resources below highlight relevant FDA guidance and regulatory information, specific FDA projects related to monitoring and assessment of MCMs, some of the ongoing FDA work related to medical product assessment in general, and key efforts relevant to MCMs that are ongoing outside of FDA.

FDA Guidance & Regulatory Information

FDA guidance and general FDA regulatory information to provide important context on the need for MCM monitoring and assessment:

FDA Contact

FDA Medical Countermeasures Initiative (MCMi)
AskMCMi@fda.hhs.gov

NOTE: Non-FDA links below are included for reference, and do not necessarily reflect FDA's positions or opinions. Consistent with FDA website policies and disclaimer, reference in any referred (linked) website to commercial products, services, manufacturers, or companies does not constitute an endorsement by the U.S. government, the Department of Health and Human Services, or FDA.

FDA Information about Past and Current MCM Monitoring and Assessment Projects

FDA Information regarding Medical Product Assessment in General

Public information from FDA about monitoring and assessment of medical products for safety and effectiveness

Additional Resources

Resources from other sources, including other government agencies, relevant to monitoring and assessment of MCMs