上市后要求与承诺:可检索数据库
正文 · 中文译文
上市后要求与承诺:可检索数据库 上市后要求与承诺:简介 上市后要求与承诺:报告 上市后要求与承诺:立法背景 上市后要求与承诺:常见问题(FAQ) 上市后要求与承诺:状态与履行类别 上市后要求与承诺:可检索数据库 上市后要求与承诺:可下载数据库文件 FDA的上市后要求与承诺可检索数据库向公众提供有关上市后要求和承诺的信息。该可检索数据库包括PMR和506B PMC,即那些针对临床安全性、临床有效性、临床药理学和非临床毒理学的研究和试验。它还包括所有未结的PMR和506B PMC,以及仅那些在过去一年内关闭(解除或履行)的PMR和506B PMC。 更新频率:每季度,约在1月、4月、7月和10月末前后 检索数据库 内容截至日期: 10/30/2026 受监管产品 药物
正文 · 英文原文
Postmarketing Requirements and Commitments: Searchable Database Postmarketing Requirements and Commitments: Introduction Postmarketing Requirements and Commitments: Reports Postmarketing Requirements and Commitments: Legislative Background Postmarketing Requirements and Commitments: Frequently Asked Questions (FAQ) Postmarketing Requirements and Commitments: Status and Fulfillment Categories Postmarketing Requirements and Commitments: Searchable Database Postmarketing Requirements and Commitments: Downloadable Database File FDA's Postmarketing Requirements and Commitments Searchable Database provides information to the public on postmarketing requirements and commitments. This searchable database includes PMRs and 506B PMCs which are those studies and trials for clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology. It also includes all open PMRs and 506B PMCs and only those closed (released or fulfilled) within the last year. Update frequency: Quarterly on or around the end of January, April, July, and October Search the Database Content current as of: 10/30/2026 Regulated Product(s) Drugs