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Open Access 01-10-2019 | Insulins | Current Opinion

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

Authors: Kelly George, Gillian Woollett

Published in: BioDrugs | Issue 5/2019

Abstract

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.

An insulin standard was first published as “Insulin Injection” in United States Pharmacopeia Version XI (USPXI) S2 and became official on 23 December 1941. An official insulin standard was issued in the USP’s Interim Revision Announcement No. 4.

USAN, administered by the AMA, usually match the INN, which are administered by the World Health Organization and available worldwide.

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Title: Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
Authors: Kelly George
Gillian Woollett
Publication date: 01-10-2019
Publisher: Springer International Publishing
Keywords: Insulins
Insulins
Published in: BioDrugs / Issue 5/2019
Print ISSN: 1173-8804
Electronic ISSN: 1179-190X
DOI: https://doi.org/10.1007/s40259-019-00374-1

At a glance: The STEP trials

Springer Medicine

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

Abstract

At a glance: The STEP trials

Springer Medicine

Abstract

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