US FDA Struggles To Meet Goals As Drug Sponsors' Meeting Requests Rise
The FDA did not expect to meet many FY 2018 goals for on-time scheduling of formal PDUFA meetings or issuing written responses in lieu of meetings.
You may also be interested in...
One of the lessons learned from the pandemic may be that virtual meetings can be used in place of an in-person session more often.
Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.
Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.