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A PET finished dose manufacturer in Ohio was cited by the FDA after investigators witnessed numerous cGMP violations and potential quality problems on a January 2014 site visit. Read More
An FDA-requested report from the National Academies of Sciences, Engineering and Medicine said it is possible to slow the spread of the opioid epidemic without limiting access to properly prescribed painkillers. Read More
Eli Lilly & Co. settled with several generic companies to resolve pending litigation over a unit dose patent for Cialis (tadalafil), delaying potential ANDA competition. Read More
The settlement, the largest of its kind, also resolves claims that the company did not meet obligations to report suspicious orders of controlled substances. Read More