We've always gotten FDA's Preliminary Comments, but not always 5 days in advance. Don't be too surprised if they come in < 5 days. I've always emailed my FDA Project Manager as that 5-day date approaches to ask when we can expect their comments.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 07-Oct-2023 10:33
From: Glen Park
Subject: Timing of FDA Preliminary Comments for EOP2 Meeting
I don't have any recent experience where this target wasn't met.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
Burien WA
United States
Original Message:
Sent: 05-Oct-2023 19:52
From: Anonymous Member
Subject: Timing of FDA Preliminary Comments for EOP2 Meeting
This message was posted by a user wishing to remain anonymous
FDA is supposed to provide preliminary comments 5 days prior to an End-of-Phase 2 (EOP2) meeting. Does anyone know if they have been meeting these targets recently?