•Regulatory requirement for drug development and approval in United States: review

ABSTRACT:In this paper a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications (SNDAs) are provided. For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed. Along with this a brief description of review steps taken by FDA is provided.INTRODUCTION:HISTORY:The research, development, and approval of a drug productis a continuous but lengthy process involving drugdiscovery, laboratory development, animal studies, clinicaltrials, and regulatory registration. This lengthy process isnecessary to assure the effectiveness and safety of the drug product. In the United States, however, no regulations were put forth until the Pure Food and Drug Act was passed by Congress in 1906. The purpose of this act is to preventmisbranding and adulteration of food and drugs yet it doesnot give the government any authority to inspect food anddrugs. The act was amended in 1912 (the SherleyAmendment) to prohibit labeling medicines with false andfraudulent claims. In 1931, the United States Food andDrug Administration (FDA) was formed. The provisions ofthe FDA are intended to ensure that:ABSTRACT: 本文以研究性新药申请（Investigational New Drug Applications, INDs）、新药申请（New Drug Applications, NDAs）、简略新药申请（abbreviated new drug applications, ANDAs）及补充新药申请（supplemental new drug applications, SNDAs）为例，简要梳理美国药品审批监管历程，并对其监管流程进行概述。针对研究性新药申请，本文探讨了科学设计临床试验方案的监管要求、机构审查委员会的职责与权限，以及治疗性研究性新药申请的适用情形。针对新药申请，本文阐述了拓展性使用申请、仿制药简略新药申请、标签变更补充新药申请的相关议题，以及咨询委员会的职责与作用。此外，本文还简要介绍了美国食品药品监督管理局（Food and Drug Administration, FDA）的药品审评流程步骤。 INTRODUCTION:HISTORY: 药品的研发与审批是一项持续但漫长的系统工程，涵盖药物发现、实验室开发、动物实验、临床试验及监管注册全环节。该漫长流程的设立，旨在保障药品的有效性与安全性。然而直至1906年美国国会通过《纯净食品药品法》，美国才首次出台相关监管法规。该法案的立法目的为防止食品与药品的假冒标注及掺假行为，但并未赋予政府对食品药品进行检查的职权。1912年，该法案经《谢利修正案》修订，新增禁止药品标注虚假或欺诈性声明的条款。1931年，美国食品药品监督管理局（Food and Drug Administration, FDA）正式成立。该局的监管条款旨在保障以下目标：