Latest From Kate Rawson
ClinROs, artificial intelligence-based algorithms will be included in approval pathway. FDA is taking a crash course on new techniques for trial assessment thanks to COVID.
Transparency On COVID Vaccine Clinical Holds Needed, Sharfstein Says; US FDA Advisory Cmtes Offer Venue
Former acting Commissioner Josh Sharfstein argues that while agency officials have done a commendable job in overall communication on COVID vaccine development, more information is needed on the clinical holds.
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.
The political spotlight on the FDA during the coronavirus pandemic has renewed a long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.
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.’
The political spotlight on FDA during the COVID-19 pandemic has renewed the long-standing debate as to whether it should be made an independent, Cabinet-level federal agency and freed from direct HHS oversight.