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EU member states will be able to purchase pandemic vaccines and other medical countermeasures as a group, under a new procurement scheme adopted Thursday. Read More
Impax said Friday it has refiled an NDA for its Parkinson’s disease drug Rytary after implementing quality systems improvements at the plant where the drug was slated to be made. Read More
Indian authorities quietly suspended Ranbaxy’s Toansa facility from exporting active pharmaceutical ingredients to Europe late last month, signaling the country’s new, tougher approach to manufacturing quality violations. Read More
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. Read More
The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
The FDA has closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
The EMA is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
A federal court tentatively approved a $60 million payout by Hospira to end a class-action lawsuit that claimed the drugmaker misled investors about its quality problems. Read More
The FDA needs to hold more presubmission meetings with generic drugmakers on topics such as stability, batch size and drug release specifications to speed up the ANDA approval process, industry representatives say. Read More