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Australian authorities have suspended a biosimilars naming initiative, pending review, in the wake of a recent World Health Organization proposal on how biosimilars should be named. Read More
The European Medicines Agency is recommending halting sales of 700 drugs that were approved based on testing data provided by CRO GVK Biosciences, following an inspection that found the Hyderabad, India, firm manipulated echocardiogram data. Read More
Drugmakers should notify the European Medicines Agency within 10 days of receiving an initial opinion on a pediatric investigation plan if they plan to request another review. Read More
The FDA warned Thursday that counterfeit versions of Eli Lilly’s popular erectile dysfunction drug Cialis were found in mail to a U.S. customer — marking the first major counterfeit incident of 2015. Read More
Authorities in the UK are urging physicians not to prescribe valproate drugs to pregnant women and to inform women who truly need the drug of potential risks to their unborn children. Read More
The European Medicines Agency has published a 100-page technical guide aimed at helping drugmakers comply with a new global standard on the reporting of individual case safety reports. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Drugmakers and industry groups are urging regulators in Australia to abandon proposed new requirements that call for larger type on drug labels and that labels be made and applied so that they cannot be damaged by opening a product. Read More