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FDA Guidance on Prophylactic DNA Vaccines: Analysis and Recommendations

The FDA has been regulating the conduct of prophylactic DNA vaccine trials in the US for nearly 15 years. This work describes the evolution of FDA policy over that period, the status of current regulatory guidance, and provides recommendations for further changes to facilitate development in this fi...

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Detalhes bibliográficos
Main Authors: Klinman, Dennis M., Klaschik, Sven, Tross, Debra, Shirota, Hidekazu, Steinhagen, Folkert
Formato: Artigo
Idioma:Inglês
Publicado em: 2009
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2847045/
https://ncbi.nlm.nih.gov/pubmed/19941989
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.vaccine.2009.11.025
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