Regulatory Open Forum

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  • 1.  Nitrosamine Assessment

    This message was posted by a user wishing to remain anonymous
    Posted 17 days ago
    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?



  • 2.  RE: Nitrosamine Assessment

    Posted 16 days ago

    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
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  • 3.  RE: Nitrosamine Assessment

    Posted 15 days ago

    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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  • 4.  RE: Nitrosamine Assessment

    Posted 4 days ago

    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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    E David Murray PhD
    Consultant Regulatory Affairs
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