'The Pazdur Effect': A Tale Of Three US FDA Oncology Advisory Committee Meetings
ODAC meetings are usually few and far between – and rarely come with good news for the sponsor. Below are some lessons learned from the bounty (three!) held this week.
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As US FDA recovers from aducanumab and looks towards an advisory committee on Pfizer’s COVID vaccine, it’s worth reflecting on how Office of Vaccine Research & Review Director Marion Gruber created positive turning points for the agency during a general discussion of vaccine approval standards at the VRBPAC.
Top officials want confirmatory trials to finish in a ‘reasonable amount of time’ and worry that ‘if 100% of them were able to confirm, then the bar’s too high.’
Richard Pazdur wants the oncology community to take a fresh look at US FDA’s expedited review programs. One big question: should there be fewer of them?