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The FDA expects to collect $312.2 million in generic drug user fees next fiscal year, with companies paying slightly less for each ANDA filing and facilities that produce active pharmaceutical ingredients (API) and finished generic products paying more. Read More
Difficulties finding the right patients for clinical trials and high active pharmaceutical ingredient costs are among the most pressing challenges in bringing new antibiotics for resistant infections to market. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
A group of brand and generic drugmakers has asked a federal judge to toss out a multidistrict class action lawsuit accusing them of colluding to delay generic versions of the painkiller Lidoderm, arguing that a patent infringement settlement between the parties was anything but anticompetitive. Read More
Two years after the EU implemented landmark pharmacovigilance legislation, European regulators are offering manufacturers and other interested parties a comprehensive look at how the region’s drug safety system actually operates. Read More
The U.S. House passed a bill this week that aims to prevent prescription drug abuse and diversion, while ensuring patient access to needed medications, by fostering greater collaboration between drug manufacturers, distributors and regulators. Read More
European regulators have approved Roche’s Gazyvaro in combination with chlorambucil as a first-line treatment for chronic lymphocytic leukemia (CLL) patients who are unable to tolerate more intensive therapies. Read More
An FDA inspection of Impax Laboratories’ Taiwan plant has uncovered apparent manufacturing violations, raising new questions about the company’s plans to launch its proposed Parkinson’s disease drug Rytary. Read More