The first major piece of legislation from the new Obama Administration was the $787-billion American Recovery and Reinvestment Act (ARRA). Passing the law proved to be a highly politicized event with both political parties drawing up lines for how legislative […]

The lives of regulatory compliance officers in the U.S. biopharma industry have been made markedly more complicated by a Supreme Court decision handed down on March 4. The case heard last fall, Wyeth vs. Levine, became a testbed for the […]

While some wind went out of the sails of the national effort to implement item-level tracking of pharmaceuticals after California postponed its e-pedigree rules in September, new developments continue to push the topic along. These events are occurring both in […]

Electronic medical record (EMR) systems are of peripheral interest to the commercial practices of the biopharma industry. Except for clinical investigations, most of the data flow going back to these manufacturers starts from the pharmacy; whereas that is an end […]