US FDA’s Califf Acknowledges There Is ‘Price To Pay’ For Missed Inspections
Commissioner Califf is questioned about the backlog of inspections and fact FDA staff are continuing to work remotely at Senate HELP Committee hearing. Senator Burr promises to be a roadblock to emergency COVID-19 funding.
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US FDA’s Biggest Post-COVID Challenge May Be Helped By Small Inspections Tweak In FDORA
The omnibus spending bill included dozens of reform provisions related to the US FDA. One seemingly minor change to FDA’s inspection authorities could end up being a big help to the challenges ahead in catching up after the COVID-19 pandemic.
Peter Marks On How He Wants To Prepare For The Next Pandemic
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.
Moderna, Pfizer Nab Unanimous Votes For Pediatric COVID Vaccines But Advisors Hint At Moderna Dosing Advantage
US FDA advisory committee members raised some concerns regarding Pfizer’s three-dose schedule for children under five, suggesting Moderna’s two-dose primary series may be preferred.