Regulatory News In Brief
This article was originally published in The Tan Sheet
OTC PPIs add blood-thinner advisory
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FDA threatens to take "swift and strong" enforcement action without warning, including filing criminal charges, against manufacturers, suppliers and distributors of tainted supplements, according to a letter sent to industry Dec. 15.
An analysis shows a benefit from using proton pump inhibitors with clopidogrel compared with using the antiplatelet drug alone, but reinforces concerns that the PPI omeprazole diminishes the efficacy of the blood thinner
Drug manufacturers that sell to the government products that do not meet specifications or that fail to report serious adverse events could face False Claims Act allegations and potentially severe penalties in the near future