胰岛素在美国是药品还是生物制剂：这有什么区别，为什么有关系？
Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
机构信息
Avalere Health LLC, 1350 Connecticut Avenue, NW, Washington, DC, 20036, USA.
FDA Policy, Avalere Health LLC, Washington, DC, USA.
出版信息
BioDrugs. 2019 Oct;33(5):447-451. doi: 10.1007/s40259-019-00374-1.
The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.
美国的胰岛素状况即将发生变化，这是一个监管事项。2020 年 3 月 23 日之后，包括胰岛素在内的、此前由美国食品和药物管理局（FDA）按药品监管的其他激素产品，尽管从科学上讲属于生物制品，但也将按监管事项归入生物制品范畴，并根据《公共卫生服务法》获得许可。这对赞助商、患者及其医生都有诸多影响。
Zotero 插件