A Framework for Assessing the Opportunity for Advanced Research, Development, and Regulatory Approval of Medical Countermeasures: A Component of BARDA's Emerging Infectious Diseases Strategy

This framework supports more efficient resource allocation by highlighting MCM candidates with the highest potential for FDA approval within existing regulatory paradigms. Given current conditions, vaccine development appears more feasible than therapeutics for the pathogens assessed, although regulatory pathways remain product- and context-specific. Close consultation with the FDA will be critical in defining appropriate regulatory strategies. This framework offers a structured, proactive approach to advance MCM development and strengthen national preparedness against emerging pathogens.