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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Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.
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.