PDUFA VII: US FDA Says Money Can’t Solve Meeting Problems
Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.
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Stakeholders believe virtual meetings should remain an option going forward, but that in-person sessions should still be convened in many cases.
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.
While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.