1. Pink Sheet

US FDA Biologics Group Emerging From Pandemic Footing – But Not Vaccines

 
• By Michael McCaughan

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.’

post- COVID-19 road
• Source: Shutterstock

The US Food & Drug Administration’s vaccine review operations are still not close to returning to pre-pandemic levels of operations, Center for Biologics Evaluation & Research Director Peter Marks said during a Reagan-Udall Foundation/Friends of Cancer Research event.

“In the area of vaccines, we are still very much under a very large load of work,” Marks said. “Vaccines are not in any way shape or form [back to] routine, every day” status

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