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.
Due to the nature of their potential use, MCMs come under the same regulatory purview as any other therapeutic agent or medical device. Successful navigation of the regulatory pathways used to authorize use is essential for making these products available to the public in a time of need. This chapter provides an understanding of the regulatory pathways involved and how they may be applied to MCMs. The chapter will focus on the regulatory system in the United States, with examples of similarities or differences with that of other countries provided when possible.
KeywordsMedical countermeasures Animal Rule Food and Drug Administration Animal model qualification Regulations
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