Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?

被引：6

作者：

George, Kelly ^{[1
]}

Woollett, Gillian ^{[2
]}

机构：

[1] Avalere Hlth LLC, 1350 Connecticut Ave NW, Washington, DC 20036 USA

[2] Avalere Hlth LLC, FDA Policy, Washington, DC 20036 USA

来源：

BIODRUGS | 2019年 / 33卷 / 05期

关键词：

D O I：

10.1007/s40259-019-00374-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：447 / 451

页数：5