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

Abstract

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 Administration (FDA) has approved more cautious efficacy… (More)
DOI: 10.1186/s12961-017-0259-8

Cite this paper

@inproceedings{Mulinari2017WhyEA, title={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}, author={Shai Mulinari and Courtney Davis}, booktitle={Health research policy and systems}, year={2017} }