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Blog & Resources Camargo Blog April 15th, 2008

505(b)(2) Pre-IND Meetings Denied

Yikes! For the first time, Camargo has two (yes, 2!) pre-IND meetings denied. Same week. Not cancelled, not postponed, not re-scheduled – denied! In both cases, the review divisions said we were on the right track, no controversy exists and that we should simply file the IND.

Wow. The purpose of the pre-IND meeting is much more than file-ability of an IND. Importantly, the client wants to know if the FDA is in agreement with the development plan, not just the first study. We also asked important questions that FDA addresses in a pre-IND response. Now what?

We don’t yet know the reason behind this. Is this a reaction to being understaffed? We can understand a meeting being scheduled later than the statutory deadline, but a pre-IND meeting is supposed to be a fundamental right.

We’ll update as we learn more about this shocking development. We are in uncharted waters.



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