11/01/2019 12:00 AM EDT
Source: U.S. Food and Drug Administration (FDA). Published: 11/2019. The purpose of this 16-page final guidance, updated in November 2019, is to assist sponsors in the clinical development of drugs for the treatment or prevention of smallpox (variola virus) infection. It revises the draft guidance for industry entitled Smallpox (Variola) Infection: Developing Drugs for Treatment or Prevention, issued on November 23, 2007. It focuses on drugs that are expected to act by inhibiting variola virus replication. Although the primary focus of this guidance is on antiviral drugs, therapeutic proteins or monoclonal antibodies also may be eligible for evaluation under the animal rule. (PDF)
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