US Food and Drug Administration device chief Jeffrey Shuren has admitted that the agency "could do a better job" at managing its pre-market review programmes, but has opposed suggestions that the US system be replaced with one similar to that in place in the EU1,2.
Although the EU system may in some instances be faster, the US system is more robust in ensuring that patients receive safe and effective products, Dr Shuren suggested at a government hearing that considered whether the FDA review system was damaging the US medtech industry...
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