Help Wanted: FDA Begins Search for New CDER Director
This article was originally published in RPM Report
Executive Summary
FDA has a lot of hard work ahead to make the new drug safety law a reality. Its first task: find a new director for the Center for Drug Evaluation & Research. That decision might be the most important one the agency makes in determining how the new law works.You may also be interested in...
Translating Obama For FDA
Jesse Goodman, FDA's new chief scientist and acting deputy commissioner, is in a pivotal role in the new Administration, as the bridge between the career staff at FDA and the incoming political leadership. His keynote address at the Food & Drug Law Institute Annual meeting is a must read for anyone looking for signs of how the Obama agenda will affect FDA.
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.
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.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: