远程监管评估由研究诚信与监测办公室开展的生物利用度/生物等效性研究。

Remote Regulatory Assessments of Bioavailability/Bioequivalence Study Conduct by the Office of Study Integrity and Surveillance.

机构信息

Office of Study Integrity and Surveillance, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, United States Department of Health and Human Services, 10903 New Hampshire Ave, Silver Spring, Maryland, 20993-0002, USA.

出版信息

AAPS PharmSciTech. 2024 Oct 10;25(7):240. doi: 10.1208/s12249-024-02967-8.

DOI:10.1208/s12249-024-02967-8

PMID:39390271

Abstract

The Office of Study Integrity and Surveillance (OSIS) in CDER in FDA coordinates and conducts inspections of sites conducting bioavailability and/or bioequivalence (BA/BE) studies supporting regulatory submissions. In response to travel restrictions during the SARS-CoV-2 (COVID-19) public health emergency, OSIS developed and began conducting remote assessments of BA/BE sites in 2020. This paper provides an overview of remote regulatory assessments (RRAs) and OSIS's approach to RRAs, including procedures, experiences, and examples of findings during RRAs. In addition, as OSIS continues to utilize RRAs while resuming inspections, some areas for improvement are discussed.

摘要

FDA 的 CDER 中的研究诚信和监测办公室（OSIS）协调并对进行支持监管提交的生物利用度和/或生物等效性（BA/BE）研究的地点进行检查。针对 SARS-CoV-2（COVID-19）公共卫生紧急情况下的旅行限制，OSIS 在 2020 年开发并开始对 BA/BE 地点进行远程评估。本文概述了远程监管评估（RRA）和 OSIS 进行 RRA 的方法，包括程序、经验以及 RRA 期间的发现示例。此外，随着 OSIS 在继续利用 RRA 的同时恢复检查，讨论了一些需要改进的领域。