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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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| Publicado no: | NPJ Vaccines |
|---|---|
| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Nature Publishing Group
2016
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5707879/ https://ncbi.nlm.nih.gov/pubmed/29263855 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1038/npjvaccines.2016.13 |
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