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German health officials called for a ban on imports to the European Union from a plant operated by Dr. Reddy’s Laboratories in India, following inspections finding poor quality controls, dirty equipment, and other shortcomings. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that takes effect Sept. 1. Read More
EMA began forming assessment teams across the European Union in 2015 to include initial marketing applications and coordination of scientific advice procedures. Read More
Clinical trial results showed Olumiant plus conventional disease-modifying antirheumatic drugs were more effective than conventional treatments alone for severe RA. Read More
Orenitram is an extended-release oral formulation of treprostinil for the treatment of pulmonary arterial hypertension that had been previously approved in other forms. Read More