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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Bibliografische gegevens
Gepubliceerd in:Br J Clin Pharmacol
Hoofdauteurs: Joppi, Roberta, Bertele, Vittorio, Vannini, Tommaso, Garattini, Silvio, Banzi, Rita
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: John Wiley and Sons Inc. 2019
Onderwerpen:
Short Reports
Online toegang: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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