The Quality Lowdown: FDA's Enhanced Drug Recall Authority

Opioid crisis gives US FDA something heparin crisis couldn’t: more drug recall authority in some cases. Meanwhile, Hanlim warning letter and Mercury Labs and Recipharm EU GMP non-compliance statements prove illuminating.

detailed illustration of a compass with Recall text, eps10 vector

This year’s congressional response to the US opioid crisis has succeeded in an area where the response to the heparin crisis of a decade earlier had failed: it delivered mandatory drug recall authority for FDA, though only for controlled substances.

Meanwhile, responses by US and EU authorities to this year’s valsartan crisis continue with even more supervision and new detection...

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