FDA Will Require Additional Long-Term Data For COX-2 Inhibitors
This article was originally published in The Pink Sheet Daily
Executive Summary
“It’s really premature for us to say right now how our requirements are going to change,” CDER Acting Director Galson says. However, the agency will “ask for more long-term data” for COX-2 inhibitors in the pipeline and those already on the market in the wake of the Vioxx withdrawal.