The COVID-19 pandemic has highlighted the importance of having access to real-world data and evidence to monitor and assess medical countermeasure (MCM) use and performance so policy makers can make more effective and rapid public health decisions, protect population health, and save lives. During public health emergencies, the use of MCMs, such as therapeutics, vaccines, and diagnostics, can be made available to the public under a range of regulatory access mechanisms.
This Rapid Expert Consultation was produced by individual members of the Standing Committee for CDC Center for Preparedness and Response. Its aim is to review and propose modifications to an initial draft list of critical federal capabilities presented by the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration that are needed to evaluate real-world safety, effectiveness, equitable distribution, access, and use of MCMs during a public health emergency. This effort draws from expert input, published literature, and lessons learned from previous public health emergencies, as well as the ongoing COVID-19 pandemic.
National Academies of Sciences, Engineering, and Medicine. 2022. Rapid Expert Consultation on Critical Federal Capabilities Needed to Evaluate Real-World Safety, Effectiveness, and Equitable Distribution and Use of Medical Countermeasures During a Public Health Emergency. Washington, DC: The National Academies Press. https://doi.org/10.17226/26574.
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