FDA Staffing, Resource Gaps Makes Applying COVID Learnings To Other Disease Areas Challenging
CBER Director Peter Marks hopes to run pilot programs that could convince Congress or industry to provide more funding that would enable FDA to offer pandemic-level communication with sponsors in 'normal' times.
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The CBER director has worried that ‘someone’ might try to end the US FDA’s hybrid work policy. Now the push against it is bipartisan.
CBER Director Peter Marks said the FDA’s remote and in-person work system is functioning well and continues to help recruitment.
Some sponsors appear to be growing antsy to meet with agency staff and advisory committees in-person, but CDER continues to schedule only virtual meetings.