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.

ABSTRACT:

Background

The advanced research, development, and regulatory approval of medical countermeasures (MCMs) for emerging pathogens remains critical to national health security. We created a conceptual framework to assess the feasibility of generating pivotal data to support FDA regulatory approval of vaccines and therapeutics against known pathogens. Our framework is intended to guide key portfolio decisions on developing MCMs for emerging viral pathogens.

Methods

This framework draws on prior experience with MCM development programs, current FDA guidance, and insights from scientific, regulatory, and public health subject matter experts. We identified key requirements that impact the ability to generate pivotal data and assessed the likelihood of meeting these requirements bas

SUBMITTER: White RC 

PROVIDER: S-EPMC12811876 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature