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Drugmakers selling into the EU will have two years to begin complying with a new set of ISO global standards that will create a unique identifier for drugs. Read More
The FDA has slammed yet another Indian drugmaker for data integrity issues: This time it rebuked Ipca Laboratories for data falsification at three of the company’s manufacturing facilities. Read More
Weighing the risks and benefits of Intercept Pharmaceuticals’ obeticholic acid, an FDA advisory committee voted unanimously 17-0 on the significance of alkaline phosphatase levels as evidence to justify an accelerated approval of the primary biliary cirrhosis candidate. Read More
FDA unveiled April 6 the new Combination Products Policy Council, which will have decision-making authority on issues relating to combination products, cross-labeled products and medical product classification. Read More
The largest drug merger of all time could be at risk of falling through after the U.S. Treasury Department late Monday issued a set of regulations that reduce the benefit of tax inversion deals. Read More