The FDA issued final guidance Friday for development of smallpox treatments as part of preparedness efforts. The guidance, "Smallpox (Variola Virus) Infections: Developing Drugs for Treatment or Prevention," is designed to assist drug manufacturers designing studies to appropriately establish the safety and efficacy of drugs to treat or prevent smallpox infection. It finalizes draft guidance issued on July 11, 2018, which revised draft guidance issued on Nov. 23, 2007. The final guidance clarifies the recommended immunological characterization of animals in key studies and includes minor editorial changes from the draft.

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