Coronavirus disease 19 (COVID-19) is an infection caused by the novel Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The pandemic spread of SARS-CoV-2 has resulted in significant health, economic, and social ramifications. There are no U.S. Food and Drug Administration (FDA)-approved prophylactic or therapeutic treatment options for COVID-19. This puts unprecedented product development pressure on the medical science community to define treatment options. Additionally, in the United States of American (USA) further regulatory and quality assurance pressures impact the FDA. The regulatory therapeutic development process is complex as it relates to product mechanism, toxicity profile, and level of efficacy. The advert of a worldwide pandemic however, advanced efficiencies within many of the regulatory agencies worldwide in order to facilitate COVID-19 treatment option development within the USA. Clinical drug development pathways can include several established approaches: investigational new drug (IND), expanded access IND, emergency IND, treatment IND, and emergency use authorization (EUA). Remdesivir, an investigational drug, and hydroxyloroquine, an FDA-approved drug for autoimmune diseases, were the two early potential therapies. This review article examines the expedited FDA review process for remdesivir and hydroxychloroquine, and analyzes data and results from early clinical studies of both drugs.

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FDA 对 COVID-19 疗法批准过程的效率

冠状病毒病 19 (COVID-19) 是由新型严重急性呼吸系统综合症冠状病毒 2 (SARS-CoV-2) 引起的感染。SARS-CoV-2 的大流行传播已对健康、经济和社会产生重大影响。没有美国食品和药物管理局 (FDA) 批准的 COVID-19 预防性或治疗性治疗方案。这给医学科学界带来了前所未有的产品开发压力，以定义治疗方案。此外，在美利坚合众国 (USA)，进一步的监管和质量保证压力对 FDA 产生了影响。监管治疗开发过程很复杂，因为它涉及产品机制、毒性特征和功效水平。然而，全球大流行的广告，提高全球许多监管机构的效率，以促进美国境内 COVID-19 治疗方案的开发。临床药物开发途径可以包括几种既定的方法：研究性新药 (IND)、扩大准入 IND、紧急 IND、治疗 IND 和紧急使用授权 (EUA)。研究药物瑞德西韦和 FDA 批准的治疗自身免疫性疾病的药物羟氯喹是两种早期的潜在疗法。这篇评论文章审查了 FDA 对瑞德西韦和羟氯喹的快速审查程序，并分析了这两种药物早期临床研究的数据和结果。扩展访问 IND、紧急 IND、治疗 IND 和紧急使用授权 (EUA)。研究药物瑞德西韦和 FDA 批准的治疗自身免疫性疾病的药物羟氯喹是两种早期的潜在疗法。这篇评论文章审查了 FDA 对瑞德西韦和羟氯喹的快速审查程序，并分析了这两种药物早期临床研究的数据和结果。扩展访问 IND、紧急 IND、治疗 IND 和紧急使用授权 (EUA)。研究药物瑞德西韦和 FDA 批准的治疗自身免疫性疾病的药物羟氯喹是两种早期的潜在疗法。这篇评论文章审查了 FDA 对瑞德西韦和羟氯喹的快速审查程序，并分析了这两种药物早期临床研究的数据和结果。