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Drug manufacturers are pressing for faster approval of antimicrobial susceptibility tests, because without them, physicians are reluctant to prescribe new antibiotic drugs, even when they have received FDA approval. Read More
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