Required Clinical Trial After Approval Database

This dataset is the main file to construct the FDA (U.S. Food and Drug Administration) Postmarketing Requirements and Commitments searchable database. Postmarketing requirements refers to studies required to be conducted under statutes or regulations after product approval. Postmarketing commitments are not required studies that sponsors conduct. Official FDA's website has an available database to provide public detailed information on postmarketing requirements and commitments studies.

本数据集为主文件，旨在构建美国食品药品监督管理局（FDA）的市场后要求与承诺可检索数据库。市场后要求系指产品批准后根据相关法律或法规必须进行的各项研究。市场后承诺则指赞助商自愿开展的非强制性研究。官方FDA网站已提供数据库，旨在向公众提供关于市场后要求与承诺研究项目的详细信息。