Engineering

Philosophy

Pathology

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Aerospace engineering

Virology

Political science

Countermeasure

Vaccination

Government (linguistics)

Smallpox

Biodefense

Regulatory science

Drug

Regulatory affairs

Administration (probate law)

Drug approval

Food and drug administration

Public administration

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Drug development

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Environmental health

Antiviral Research

The development and approval of brincidofovir for the treatment of smallpox, a disease that was eradicated from the world over 40 years ago, has resulted in the second antiviral approved via the Medical Countermeasure Initiative (MCMi) to combat this disease. Approval of brincidofovir required a unique regulatory approach based on the FDA Animal Rule, and development was supported by many years of research and collaboration among academic investigators, the pharmaceutical industry and multiple government agencies. This article summarizes the FDA regulatory pathway and describes the challenges involved.

Benefit-risk assessment for brincidofovir for the treatment of smallpox: U.S. Food and Drug Administration's Evaluation