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.
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The change would let FDA forcibly pull prescription and over-the-counter drugs off the market just like vaccines, medical devices and other products.
Aurobindo failed to properly investigate problems with carcinogenic impurities in active pharmaceutical ingredients, warning letter says.
Draft guidance outlines how manufacturers and distribution partners should prepare for, plan and conduct voluntary recalls of drugs and other FDA-regulated products.