Over the past year, the Severe Acute Respiratory Syndrome Coronavirus 2 pandemic has led to rapid advancement regarding therapeutics, vaccines, and testing. In the United States, the Food and Drug Administration (FDA) is the agency ensuring standardization, reproducibility, and meeting benchmarks of safety and efficacy for these products. Among medical professionals and the public, there are often questions about the role of regulation, product development and approval, and terminology often used in regard to the FDA. This manuscript will serve as an introduction to the FDA, clarify the steps of drug development and approval, review terms related to product use, and discuss the role of the medical community and industry.

中文翻译：

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了解药物开发：食品和药物管理局入门

在过去的一年中，严重急性呼吸系统综合症冠状病毒 2 大流行导致治疗、疫苗和测试方面取得了快速进展。在美国，食品和药物管理局 (FDA) 是负责确保这些产品的标准化、可重复性以及满足安全性和有效性基准的机构。在医疗专业人士和公众中，经常有关于监管、产品开发和批准的作用以及 FDA 经常使用的术语的问题。这份手稿将作为对 FDA 的介绍，阐明药物开发和批准的步骤，审查与产品使用相关的术语，并讨论医学界和行业的作用。