Barr Plan B "Not Approvable" Switch Decision Puts CDER Director In Hot Seat
This article was originally published in The Pink Sheet Daily
Executive Summary
CDER Acting Director Galson takes full responsibility for "not approvable" action; says he did not consider outside pressure in making his decision. "Not approvable" letter issued because the data were not "adequate" for the "next level up."
You may also be interested in...
Plan B OTC Submission Deemed "Not Approvable"
Barr will have to detail a mechanism for drugstores to screen women less than 16 years of age for nonprescription use of the emergency contraceptive. FDA's decision goes against the recommendation of its advisory panels.
Energy & Commerce Committee Closely Monitors First Post-McClellan ODAC Meeting
Rep. Deutsch and Energy & Commerce Committee staffers get first row reserved seat at May 3 Genta’s Genasense and Allos’ Excelar meeting. Meeting serves as the litmus test for concerns that agency review process will “revert” to overregulation by FDA in post-Commissioner McClellan period.
Pazdur’s Big Moment: ‘Project Odyssey’ Webinar Gives Oncology Chief External Buy-In On His Ideas To Revamp ODAC
OCE Director Richard Pazdur is known for cultivating 'Pazdur moments' during advisory committees when he feels the conversation has gone off track. A recent webinar with ODAC members created a perfect opportunity to promote his agenda.