Drop in US drug approvals but no similar trend in the EU

Pharmaceutical Executive

28 March 2017 - NDA Group announced findings from their fourth annual comparison of drug approvals in Europe and the United States, ahead of this year's DIA EuroMeeting in Glasgow, UK.

The report – based on preliminary research figures from the EMA and FDA websites in January 2017 – found that there has been a drop in US approvals but not in EU. For 2016 there were 74 new drug approvals granted in the US and EU. Of these new products, 19 were approved only in the EU, 19 only in the US, and 36 were granted in both regions. However, 17 drugs that were approved in the EU in 2016 had received prior approval in 2015 or earlier in the US, while only six products registered in the US in 2016 were previously approved in the EU.

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Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe , US , Regulation