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Expert Review of Vaccines
(Jun 2017)
Regulating vaccines at the FDA: development and licensure of Zika vaccines
Marion F. Gruber,
Philip R. Krause
Affiliations
Marion F. Gruber
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
Philip R. Krause
Center for Biologics Evaluation and Research, U.S. Food and Drug Administration
DOI
https://doi.org/10.1080/14760584.2017.1324304
Journal volume & issue
Vol. 16, no. 6
pp. 525 – 527
Abstract
Read online
No abstracts available.
Keywords
accelerated approval
animal rule
immune response
infectious disease
licensure pathways
surrogate marker
us fda
vaccine development
zika
vaccine approval process
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