Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Division of Antiviral Products, Office of Antimicrobial Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
Lancet Infect Dis. 2019 Jun;19(6):e221-e224. doi: 10.1016/S1473-3099(18)30788-6. Epub 2019 Mar 7.
The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.
特考韦瑞玛的研发及其最终获得批准用于天花的抗病毒治疗，而天花这种疾病在近 40 年前已在全球范围内被根除。这需要一种基于美国食品和药物管理局的动物规则的独特监管方法。我们总结了监管途径，并描述了所涉及的挑战。
