US FDA’s Marks Was Frustrated About Slow Completion Of 2021 Comirnaty Review
Executive Summary
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.
You may also be interested in...
FDA’s Cell, Gene Therapy Office Head Wilson Bryan Set To Retire
OTAT Director Bryan, who has worked at the FDA for more than 20 years, will depart by the end of March as the agency’s cell and gene therapy operations are poised for a major overhaul and a large number of new hires.
US FDA Biologics Group Emerging From Pandemic Footing – But Not Vaccines
The COVID-19 pandemic is definitely not over when it comes to the workload facing the US FDA’s vaccine review team, even as the other biologics review operations get back ‘toward normal.’
US FDA ‘Actively Working’ To Fill Vaccine Leadership Positions Ahead Of Next Round Of COVID Reviews
As decisions on additional boosters and childhood inoculations loom, CBER Director Peter Marks is still heading the vaccines division on an acting basis since the departures of Marion Gruber and Philip Krause last year. Who might succeed them?