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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...
| Autores principales: | , , , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
BMJ Publishing Group Ltd.
2015
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| Materias: | |
| 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 |