Woodcock to the Rescue: Is CDER Approving More Products?
This article was originally published in RPM Report
The financial community believes in Janet Woodcock: some analysts are predicting an improving climate for drug approvals based on her return to FDA's Center for Drug Evaluation & Research. Woodcock says standards aren't changing-but she does seem to relish making the tough decisions that make some approvals possible.
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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.
Janet Woodcock returned to the Center for Drug Evaluation & Research after four years as FDA commissioner Andrew von Eschenbach's right-hand woman. We talked to her about why she went back, how things have changed and the challenges that lie ahead.
Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.