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INTERACT Meeting Timing Remains Point Of Confusion

 
• By Derrick Gingery

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.

  • FDA officials said meeting acceptance will depend on the review division

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

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