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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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| Publicat a: | Br J Clin Pharmacol |
|---|---|
| Autors principals: | , , , , |
| Format: | Artigo |
| Idioma: | Inglês |
| Publicat: |
John Wiley and Sons Inc.
2019
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| Matèries: | |
| Accés en línia: | 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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