Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, Food and Drug Administration, DHHS, 1451 Rockville Pike, WOCII Room 3312, Rockville, MD 20852, USA.
Expert Rev Vaccines. 2011 Jul;10(7):1011-9. doi: 10.1586/erv.11.52.
Vaccines for prevention or treatment of infectious diseases are biological products that are regulated by the Office of Vaccines Research and Review in the Center for Biologics Evaluation and Research of the US FDA. The legal framework for the regulation of vaccines derives primarily from Section 351 of the Public Health Service Act and from certain sections of the Federal Food, Drug and Cosmetic Act (FFD & C Act). The FDA Amendments Act of 2007 (FDAAA 2007) includes extensive modifications to the FFD & C Act. This article provides an overview of the review process for preventive vaccines and highlights applicable statutory provisions. In addition, this article will discuss changes in the pre-and post-licensure evaluation process for preventive and therapeutic infectious disease vaccines since implementation of the FDAAA 2007.
疫苗用于预防或治疗传染病，属于由美国食品和药物管理局（FDA）下属的生物制品评估与研究中心疫苗研究与评估办公室监管的生物制品。疫苗监管的法律框架主要源自《公共卫生服务法案》第 351 节和《联邦食品、药品和化妆品法案》（FFDCA）的某些章节。2007 年食品药品监督管理局修正案（FDAAA 2007）对 FFDCA 进行了广泛的修订。本文概述了预防性疫苗的审查流程，并重点介绍了适用的法定条款。此外，本文还将讨论自 2007 年 FDAAA 实施以来，预防性和治疗性传染病疫苗在上市前和上市后评估流程方面的变化。
