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Elite Laboratories has been given a warning letter due to a failure to develop adequate written procedures, particularly for adverse drug experiences (ADEs). Read More
The UK’s price watchdog is recommending Bayer’s eye medicine Eylea as a first-line treatment for vision loss due to fluid buildup in the retina, provided the company discounts its price. Read More
Lawmakers have called on the Department of Justice to investigate whether Mylan violated the law by misclassifying its severe allergy treatment EpiPen as a generic in the Medicaid Drug Rebate Program. Read More
Despite significant potential savings in time and money, drug and medical device manufacturers have been slow to embrace continuous manufacturing, an FDA technology official said. Read More
The FDA is looking to increase its post-marketing inspections of manufacturing facilities, mainly within six months to two years after an approval, focused on ensuring that quality is maintained after a company scales up to commercial production. Read More