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The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generic drugmakers submitting ANDAs that indicate impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
A new report from the Italian Medicines Agency says that 10 percent of Italian hospitals register pharmaceutical thefts, a problem that the European pharmaceutical industry hopes to end with a pan-European verification system set to go live by 2017. Read More
The European Medicines Agency has issued revised guidelines that aim to ease overly burdensome postmarket monitoring and reporting requirements under the EU’s 2010 good pharmacovigilance practices (GVP) regulations. Read More
A federal judge has tossed out all claims brought against Pfizer and Ranbaxy by retailers and distributors in a larger lawsuit that alleges the two companies colluded to delay a generic version of Pfizer’s blockbuster cholesterol drug Lipitor. Read More
Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy. Read More
The FDA has again rejected Amarin’s appeal for the agency to reinstate a special protocol assessment (SPA) on a phase III study of its triglyceride drug Vascepa, a move that casts doubt on the drugmaker’s ability to expand its indication on the fish oil-based product. Read More
Australia’s Department of Health has moved the division overseeing the import and export of certain drugs from the department’s office of chemical safety to the Therapeutic Goods Administration’s office of scientific evaluation as part of a move to better align agency functions. Read More