FDA Insider: Agency Looks Carefully Inside for New CDER Head
This article was originally published in RPM Report
Executive Summary
FDA’s Center for Drug Evaluation & Research still doesn’t have a permanent director. The longer the search goes on, the more likely the candidate will come from inside.
You may also be interested in...
Woodcock to the Rescue: Is CDER Approving More Products?
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.
Woodcock to the Rescue: Is CDER Approving More Products?
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.
The New User Fee Rules: FDA Sacrifices Timeliness, Tries to Save Predictability
Janet Woodcock is returning as director of CDER at a time when the user fee program is in flux and FDA is struggling to implement new drug safety initiatives. For 2008, timeliness of reviews will slip, but with any luck, the transparency and predictability of PDUFA will continue.