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
Descripción
Sumario: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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