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After French drug trial tragedy, European Union issues new rules to protect study volunteers

External Link - Source: Science

The European Medicines Agency (EMA) has issued new, stricter rules for studies that test drugs in people for the first time. They aim to better protect participants in such first-in-human studies—often healthy volunteers who receive a financial reward. The guideline, which was issued on 25 July, will take effect in February 2018. It comes in the wake of a tragedy in a French drug study last yearthat led to the death of one man and serious neurological damage in four others. But some say the revision isn’t going for enough.

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