Morning all,
I cannot speak to the timeline for the assessment pre-submission but I would say that the nitrosamine piece is an incredibly important regulatory piece these days and it is crucial to ensure that assessment is performed thoroughly before MAA/NDA and shows no red flags as this will bring a review to a grinding halt.
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Patricia Smith PhD, RAC
Senior Director, Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Information
Saint-Laurent QC
Canada
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Original Message:
Sent: 07-Sep-2023 09:47
From: Tom Stothoff
Subject: Nitrosamine Assessment
NDA. We are in Phase 3 now and have not had any requests from FDA or EU authorities for an assessment.
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Tom Stothoff
Senior Director, Regulatory Affairs CMC
Chicago
Original Message:
Sent: 05-Sep-2023 16:01
From: Anonymous Member
Subject: Nitrosamine Assessment
This message was posted by a user wishing to remain anonymous
Per recent FDA guidance on Nitrosamine, a Drug product manufacturer should conduct risk assessments to determine the potential for
nitrosamine impurities in drug products. Should the risk assessments be conducted for an IND containing a Phase 2/3 clinical trial or the NDA application?