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Federal efforts to protect the drug supply chain continue to bear fruit, with the FDA’s Office of Criminal Investigations announcing criminal charges for another counterfeit operation. Read More
A new report pushes states to agree on common standards for traditional compounding operations and recommends a series of best practices for all to follow. Read More
A new analysis of state regulatory controls on compounding operations has found significant variance in their oversight and enforcement of traditional compounding operations. Read More
Robert Califf was sworn in as the new commissioner of the FDA Feb. 25 after the Senate confirmed him on Feb. 24 in a roll call vote of 89 to 4. Read More
The FDA expects drugmakers to have quality agreements with their suppliers, but how those agreements are crafted says a lot about a company’s internal auditing program. 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
The European Medicines Agency and the European Commission today published new track-and-trace safety requirements affecting all drugmakers doing business in EU countries. 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
Celldex Therapeutics has pulled the plug on a Phase 3 trial of immunotherapy Rintega in patients with EGFRvIII-positive glioblastoma after a mid-trial analysis showed the candidate fared worse than a control group. Read More
France’s National Agency for Medicines and Health Products Safety has ordered French vaccine maker Theravectys to halt production at its Villejuif plant for seven months after finding numerous GMP deficiencies. Read More
The European Medicines Agency has launched its PRIority MEdicines initiative to accelerate breakthrough therapies that offer a major therapeutic advantage over existing treatments. Read More