Per recent FDA guidance on Nitrosamine, a Drug product manufacturer should conduct risk assessments to determine the potential fornitrosamine impurities in drug products. Should the risk assessments be conducted for an IND containing a Phase 2/3 clinical trial or the NDA application?
NDA. We are in Phase 3 now and have not had any requests from FDA or EU authorities for an assessment.
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.
I agree completely with Patricia. This is a key area of focus for the FDA and they are being conservative. For one API and subsequent drug product, Health Canada and EMA are applying ICH Q3B and the FDA is at ppm limits.
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