Vanda's Atypical Approval: Is It Time to Rethink Attitudes Toward FDA?
This article was originally published in RPM Report
The atypical antipsychotic iloperidone took a treacherous route to market. What does FDA’s decision-making from not approvable to approval in 10 months say about approval standards?
You may also be interested in...
Three top FDA officials sat down with The RPM Report at their White Oak campus to discuss the top drug regulatory issues. On the table for discussion: drug safety, comparative effectiveness and the future of drug development.
Companies as diverse as CV Therapeutics, UCB, GSK, Pozen and Biovail are all smiles about becoming unwitting guinea pigs in the new era of drug safety. None could have expected to be pioneers in facing new post-marketing burdens-but all are thrilled that their products were approved at all. And most have seen an immediate payback for their investors.
With landmark advisory committee meetings coming up, we take a look back at some of the memorable panel meetings over the last 20 years. This is Part II in the series.