Center for Inflammatory Bowel Disease, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
Inflamm Bowel Dis. 2011 Dec;17(12):2585-93. doi: 10.1002/ibd.21712. Epub 2011 Apr 11.
All medicinal compounds sold in the United States for inflammatory bowel disease (IBD) are regulated by the Food and Drug Administration (FDA) via a number of regulations dating back to 1906. The primary contemporary role of the FDA is in the assessment of safety and efficacy, and subsequent marketing, of medications based on preclinical and clinical trial data provided by sponsors. This includes pharmacokinetic, toxicology and clinical studies, and postapproval safety monitoring. Mesalamine formulations, budesonide, and biologic therapies have all been assessed for efficacy and safety in IBD by the FDA via large randomized controlled trials (RCTs). There has been considerable evolution in the endpoints used by the FDA to approve medications for IBD, and the mechanisms through which newer agents have been approved. This review examines the methods of drug approval by the FDA, the bench-marks used to approve drugs for IBD, and recent controversies in the FDA's role in drug approval in general.
所有在美国销售的用于治疗炎症性肠病 (IBD) 的药物化合物都受到食品和药物管理局 (FDA) 的监管，这些法规可以追溯到 1906 年。FDA 的主要作用是根据赞助商提供的临床前和临床试验数据，评估药物的安全性和有效性，然后进行市场营销。这包括药代动力学、毒理学和临床研究，以及上市后安全性监测。FDA 通过大型随机对照试验 (RCT) 评估了美沙拉嗪制剂、布地奈德和生物疗法在 IBD 中的疗效和安全性。FDA 用于批准 IBD 药物的终点以及批准新型药物的机制发生了相当大的变化。这篇综述考察了 FDA 的药物批准方法、用于批准 IBD 药物的基准以及 FDA 在药物批准方面的一般作用的最新争议。
