Regulatory Pathways for Medical Products Used in Biodefense

Medical countermeasures (MCMs) are products that may be used in the event of a potential public health emergency resulting from a terrorist attack or natural disaster involving a chemical, biological, radiological, or nuclear (CBRN) insult. MCMs can be used for the diagnosis, prevention, or treatment of conditions associated with these threats. There are three major classes of MCMs: (1) biologic products such as vaccines, blood products, and antibodies, (2) drug products such as antimicrobials or antivirals, and (3) medical devices including diagnostic tests and protective equipment. One or more of these products may be needed during a public health emergency.