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The FDA Vs. AVEO's Tivozanib: Who Does The Dying?
What a bunch of BS coming from FDA & Pazdur today:
FDA oncology chief Pazdur vows to accelerate "breakthrough" drug R&D
May 31, 2013 | By John Carroll
CHICAGO -- The FDA's oncology chief, Richard Pazdur, used his turn in front of the press mob at ASCO today to make some very public vows about his commitment to the newly launched breakthrough-drug program, that intriguing new classification for certain stellar therapeutic programs that will be extended VIP status at the agency.
Pazdur stressed that any drug development team working on a breakthrough drug will have no trouble getting steady feedback from the agency, and in particular the oncology division he runs. Pazdur and the agency view these drugs as potentially "transformative" therapies capable of changing the course of patients' lives. And the agency is committed to spend time in an "iterative fashion," holding monthly meetings and teleconferences to advise teams on accelerating the whole development process, with a goal of quickening final marketing decisions.
This is going to be a "different communication structure," Pazdur promises, "with much more of a continuous dialogue with sponsors." Together, regulators and development teams can change endpoints, downsize trial sizes in light of the data they're seeing and expedite reviews--adaptive research with regulatory input.
ALMOST FUNNY IF NOT PATHETIC.
May 31, 2013. 06:18 PM
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