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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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Dettagli Bibliografici
Pubblicato in:Br J Clin Pharmacol
Autori principali: Joppi, Roberta, Bertele, Vittorio, Vannini, Tommaso, Garattini, Silvio, Banzi, Rita
Natura: Artigo
Lingua:Inglês
Pubblicazione: John Wiley and Sons Inc. 2019
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Accesso online: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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