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Manufacturers that sell drugs in the European Union will soon have to make publicly available clinical trial data supporting approval of those products, under a landmark transparency policy adopted yesterday by the European Medicines Agency. Read More
Eli Lilly has given up on its lupus drug candidate tabalumab after researchers determined the efficacy data from two Phase III studies were not strong enough to support a regulatory submission. Read More
The FDA warned a Georgia-based compounder and repackager for poor cleaning practices that apparently led to patients becoming infected by contaminated products. Read More
The FDA expects to have standardized formats for ANDA data submissions in place and required for all filers by the first half of fiscal year 2017. Read More
The FDA issued a warning letter to injectables giant Hospira after an investigation of its Victoria, Australia, plant uncovered significant good manufacturing practice violations, including a failure to adequately investigate failed batches and determine levels of impurities in distributed products. Read More
Allergan’s eye implant therapy Ozurdex can now be used on the entire diabetic macular edema (DME) patient population, following an FDA expansion of the product’s indication this week. Read More
European regulators are proposing changes to development guidelines of drugs treating the gastrointestinal disorders ulcerative colitis and Crohn’s disease to better understand how the products work in children as well as adults. Read More
Drug sponsors submitting plans to test products in children in Europe need to provide the European Medicines Agency with information on all formulations they are developing, according to a finalized pediatric investigation plan that took effect this week. Read More