Pradaxa and Actos: Is Non-Preservation of Documents an Emerging Trend?
When a US District Court judge fined Boehringer Ingelheim almost $1 million at the end of last year for failure to preserve documents regarding the blood thinner Pradaxa, the decision served as a precursor to a similar position taken by the Court in regards to the Actos portfolio. The Actos manufacturer, Takeda Pharmaceuticals, was cited […]
FDA’s Special Report on Product Safety and Quality
The U.S. Food and Drug Administration (FDA) recently issued a special report on product safety and quality designed to meet the challenges imposed by the increasing number of FDA-regulated imports and a complex global supply chain. The special report, entitled Pathway to Product Safety and Quality, reports that between 10 and 15% of all food […]