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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
Following months of pressure from industry, the FDA has released draft guidance on biosimilars labeling, recommending that sponsors of biosimilars incorporate into product labeling information from the reference product labeling. Read More