Comparison of content of FDA letters not approving applications for new drugs and associated public announcements from sponsors: cross sectional study

Objectives To describe the content of non-public complete response letters issued by the US Food and Drug Administration (FDA) when they do not approve marketing applications from sponsors (drug companies) and to compare them with the content any subsequent press releases issued by those sponsors De...

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Detalhes bibliográficos
Publicado no:BMJ
Main Authors: Lurie, Peter, Chahal, Harinder S, Sigelman, Daniel W, Stacy, Sylvie, Sclar, Joshua, Ddamulira, Barbara
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group Ltd. 2015
Assuntos:
Research
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4462714/
https://ncbi.nlm.nih.gov/pubmed/26063327
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.h2758
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