So, in classifying your proposed change, I would think an extension of hold time will be in the realm of a manufacturing change. If we go by the Guidance for Industry,
Changes to an Approved NDA or ANDA, I don't see extension of hold time as being classified a major change. This seems to fit better as a moderate change so a CBE-30 should suffice with the appropriate data to scientifically justify the change and its impact (if any) on identity, strength, quality, purity, and potency. I hope this helps!
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Paris Hamilton, Ph.D.
Regulatory Affairs R&D Chemistry Manager
SC
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Original Message:
Sent: 13-Jul-2018 07:22
From: Vini Modi
Subject: Hold time study for an approved ANDA
Hello
I am trying to look for guidance on what kind of submission we should do to extend the hold time for an approved ANDA nonsterile liquid product? Can it be a CBE30 with available stability data or it has to be a PAS?
Thanka in advance!
Vini Modi, MS
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Vini Modi
Associate, RA/Compliance
PA
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