First vaccine approval under the FDA Animal Rule

The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indicat...

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Detalles Bibliográficos
Autores principales: Beasley, David W C, Brasel, Trevor L, Comer, Jason E
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2016
Materias:
Perspective
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707879/
https://www.ncbi.nlm.nih.gov/pubmed/29263855
http://dx.doi.org/10.1038/npjvaccines.2016.13
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author Beasley, David W C
Brasel, Trevor L
Comer, Jason E
author_facet Beasley, David W C
Brasel, Trevor L
Comer, Jason E
author_sort Beasley, David W C
collection PubMed
description The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed.
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spelling pubmed-57078792017-12-20 First vaccine approval under the FDA Animal Rule Beasley, David W C Brasel, Trevor L Comer, Jason E NPJ Vaccines Perspective The US Food and Drug Administration’s Animal Rule was established to facilitate licensure of new products for life-threatening conditions when traditional efficacy trials in humans are unethical or impractical. In November, 2015 BioThrax became the first vaccine to receive approval for a new indication via this pathway. The basis for this approval and use of Animal Rule or other non-traditional approval pathways for licensure of vaccines for serious conditions are discussed. Nature Publishing Group 2016-08-25 /pmc/articles/PMC5707879/ /pubmed/29263855 http://dx.doi.org/10.1038/npjvaccines.2016.13 Text en Copyright © 2016 The Author(s) http://creativecommons.org/licenses/by/4.0/ This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/
spellingShingle Perspective
Beasley, David W C
Brasel, Trevor L
Comer, Jason E
First vaccine approval under the FDA Animal Rule
title First vaccine approval under the FDA Animal Rule
title_full First vaccine approval under the FDA Animal Rule
title_fullStr First vaccine approval under the FDA Animal Rule
title_full_unstemmed First vaccine approval under the FDA Animal Rule
title_short First vaccine approval under the FDA Animal Rule
title_sort first vaccine approval under the fda animal rule
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5707879/
https://www.ncbi.nlm.nih.gov/pubmed/29263855
http://dx.doi.org/10.1038/npjvaccines.2016.13
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