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?
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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.
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.’
Peter Marks predicts that staffing challenges within CBER can be alleviated by offering employees the flexibility to work remotely – permanently. With important posts in the vaccines office still to be hired, it could be an important incentive.