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.’
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The tandem reviews by a US FDA advisory committee of two RSV vaccine candidates from Pfizer and GSK is a milestone event for the agency. They are the first non-COVID vaccine BLAs to go to committee since the pandemic began – and the debut of the new vaccine office leadership at FDA.
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 group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.