Browse By Tags

Are reform efforts aimed at controlling the costs of physician-dispensed drugs having the desired effect? It appears not, at least in California, Florida, Pennsylvania, Illinois, and Tennessee. In recent years, at least 20 states have made legislative...

If one was trying to track hot topics and trends in California workers’ comp, a good place to start would have been a recent March conference in Oakland attended by many prominent stakeholder representatives. Oakland’s Marriott Hotel was...

By Erica J. Pascal Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) in 2009 to create a framework for the introduction of biosimilar and interchangeable drugs into the US market. Like the predecessor Hatch-Waxman Act,...

The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers , which provides answers to questions from public comments received on the...

In response to the U.S. Supreme Court's holding in Pliva v. Mensing , 131 S. Ct. 2567 (2011), [ enhanced version available to lexis.com subscribers ], that federal laws and regulations preempted state failure-to-warn claims, the U.S. Food and Drug...

LONDON - (AP) GlaxoSmithKline PLC says U.S. patent litigation over the Omega-3 Lovaza drug has been settled, allowing generic drug company Apotex to eventually bring a competitor to market. Glaxo said Wednesday that Norway's Pronova BioPharma, which...