1. Pink Sheet

PDUFA Meetings: US FDA Wants Sponsors To Prioritize Issues For Discussion

 
• By Sue Sutter

But the agency should explain why different meeting types are granted than requested or denied entirely, industry representatives said during session on meeting management best practices.

In-person meeting
The FDA is granting more than 60% of all in-person meeting requests under PDUFA. • Source: Shutterstock

US Food and Drug Administration staff want sponsors to better focus and prioritize issues for discussion at formal meetings under the Prescription Drug User Fee Act program.

Key Takeaways

  • The FDA wants sponsors to focus their questions for discussion at PDUFA meetings and recommends that patient advocate presentations be scheduled for the latter part of the meeting so pressing issues can be addressed first.

  • Industry wants more explanation from the agency on why meetings are not granted or converted to written response-only format

Sponsors also should explain in meeting requests why an in-person or virtual meeting is needed rather than a

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