INTERACT Meeting Timing Remains Point Of Confusion

US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.

ambiguity — The development timing for an INTERACT meeting remains a regulatory gray area. • Source: Shutterstock

Sponsors may have been excited to expand the US Food and Drug Administration’s INTERACT meeting program, but many are finding it difficult to access, in part because the acceptance requirements remain a regulatory gray area.

Key Takeaways

Sponsors want more clarity on the ideal time in development to conduct an INTERACT meeting.

The Initial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting is designed to help sponsors early in drug...

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