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

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 l...

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Detalles Bibliográficos
Autores principales: George, Kelly, Woollett, Gillian
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2019
Materias:
Current Opinion
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790337/
https://www.ncbi.nlm.nih.gov/pubmed/31388968
http://dx.doi.org/10.1007/s40259-019-00374-1
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author George, Kelly
Woollett, Gillian
author_facet George, Kelly
Woollett, Gillian
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description 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.
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spelling pubmed-67903372019-10-17 Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter? George, Kelly Woollett, Gillian BioDrugs Current Opinion 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. Springer International Publishing 2019-08-06 2019 /pmc/articles/PMC6790337/ /pubmed/31388968 http://dx.doi.org/10.1007/s40259-019-00374-1 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Current Opinion
George, Kelly
Woollett, Gillian
Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title_full Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title_fullStr Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title_full_unstemmed Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title_short Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
title_sort insulins as drugs or biologics in the usa: what difference does it make and why does it matter?
topic Current Opinion
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6790337/
https://www.ncbi.nlm.nih.gov/pubmed/31388968
http://dx.doi.org/10.1007/s40259-019-00374-1
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