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Why European and United States drug regulators are not speaking with one voice on anti-influenza drugs: regulatory review methodologies and the importance of ‘deep’ product reviews

BACKGROUND: Relenza represents the first neuraminidase inhibitor (NI), a class of drugs that also includes the drug Tamiflu. Although heralded as breakthrough treatments in influenza, NI efficacy has remained highly controversial. A key unsettled question is why the United States Food and Drug Admin...

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Detalhes bibliográficos
Publicado no:Health Res Policy Syst
Main Authors: Mulinari, Shai, Davis, Courtney
Formato: Artigo
Idioma:Inglês
Publicado em: BioMed Central 2017
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5680823/
https://ncbi.nlm.nih.gov/pubmed/29121959
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s12961-017-0259-8
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