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Food and Drug Administration vs European Medicines Agency: Review times and clinical evidence on novel drugs at the time of approval
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) now have expedited review procedures for new drugs. We compared the review times of medicines licensed by the 2 agencies and explored differences in the evidence submitted. In 2015–2017 the FDA licensed 113 drugs, 66 of which...
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| Publicado no: | Br J Clin Pharmacol |
|---|---|
| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
John Wiley and Sons Inc.
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6983504/ https://ncbi.nlm.nih.gov/pubmed/31657044 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.14130 |
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