Dear Anonymous,
For clarity, nonclinical is a term not used for CMC activities. You can look up the definition in 21 CFR 58, usually the chemical characterization and studies are excluded from the use of nonclinical.
Regardless, without knowing if your pre-IND type B meeting included CMC as a discipline in your meeting information package to support the pre-IND meeting, it is hard to respond to your question. If you have a specific question for the agency related to the sterilization and stability activities you could submit these under the P-IND with the background information to support your question or reason for submitting any additional information. I would contact the Division's project manager ahead of the submission to understand the timing for a response as you won't be under a PDUFA driven timeline unless you told the Agency that would be requesting a separate meeting for CMC.
Without knowing more specifics related to the sterilization and stability topics, which are typically outlined in guidance and ICH for early phase studies, perhaps pursuing an RA consultant would be a good course of action so you are fully advised of any risks and timing impact to your IND submission if planned in the near future.
Good luck,
Dar
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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 12-Aug-2021 09:19
From: Anonymous Member
Subject: Nonclinical protocols submission during Pre-IND
This message was posted by a user wishing to remain anonymous
HI,
We had a pre-IND type B meeting with FDA and as a follow up we would like to submit nonclinical protocols (sterilization and stability protocols) to the FDA for review and comments. We have not filed an initial IND application yet, as we are still finalizing the clinical protocols and IB. Are we allowed to submit nonclinical protocols under a Pre-IND?
Thanks!