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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
Health Canada has expanded its initial import ban on Apotex’s finished product facility in Bangalore, India, to include the generics makers’ raw materials plant in the city, as well as other India manufacturers. Read More
In a defeat for the pharmaceutical industry, a federal appeals court has upheld a California county ordinance that requires drug manufacturers to collect and dispose of unwanted medicines, a program that advocates say will serve as a national model. Read More
Salix Pharmaceuticals and Progenics Pharmaceuticals said they had received FDA clearance for a new indication on their opioid-induced constipation drug Relistor. Read More