US COVID-19 Vaccine Booster Plan Also Boosts Pressure On FDA
The plan’s White House announcement was described as a transparency move, but meeting its 20 September target start date requires both the FDA and ACIP to act quickly on boosters.
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US FDA’s Marks Was Frustrated About Slow Completion Of 2021 Comirnaty Review
CBER Director Peter Marks told Janet Woodcock in an email that he thought reviewers were treating the BLA for the first fully approved COVID-19 vaccine as a conventional review or learning exercise.
A Little Help From His Friends: Califf Requests Patients Help US FDA Fight Misinformation
The idea seems to stem from thinking that human interaction is the best way to combat rumors and false statements.
US FDA Denies Petition Seeking Freeze On Russian Companies’ Regulatory Activities
Agency tells former OOPD director Tim Coté it doesn't have the authority to consider sponsor’s country of origin when determining whether to act on applications. Despite the denial of petition, FDA continues to support Ukraine.