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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Detalles Bibliográficos
Autores principales: Lurie, Peter, Chahal, Harinder S, Sigelman, Daniel W, Stacy, Sylvie, Sclar, Joshua, Ddamulira, Barbara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2015
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4462714/
https://www.ncbi.nlm.nih.gov/pubmed/26063327
http://dx.doi.org/10.1136/bmj.h2758

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4462714/
https://www.ncbi.nlm.nih.gov/pubmed/26063327
http://dx.doi.org/10.1136/bmj.h2758

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