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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
Batches of hastily assembled drug products distributed too soon and failure to document quality systems activities were among a host of GMP issues drugmakers violated, sometimes more than a year after the FDA first expressed concerns about companies’ repeated lapses during inspections. Read More
The FDA is clarifying that if an institutional review board is found to be noncompliant, the FDA may require the IRB to withhold approval of new clinical studies, stop enrolling new subjects in ongoing studies, and to terminate ongoing studies. Read More