US FDA/Industry Thinking PDUFA VIII Could Be A Hybrid Negotiation
Virtual meetings proved successful, and could be allowed again when the next round of user fee reauthorization talks convene.
You may also be interested in...
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.
A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.
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.