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Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study
Objective To determine if drugs approved through the Food and Drug Administration’s expedited development and review pathways have different rates of safety related label changes after approval compared with drugs approved through standard non-expedited pathways. Design Retrospective cohort study. S...
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| Publicado no: | BMJ |
|---|---|
| Main Authors: | , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
BMJ Publishing Group Ltd.
2017
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5588044/ https://ncbi.nlm.nih.gov/pubmed/28882831 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmj.j3837 |
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