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    Perrigo: Pharmaceutical industry should question nitrosamine risk assessments

    The pharmaceutical industry needs to closely evaluate suppliers’ testing to ensure that accurate methods are being used to assess nitrosamine risks in drug products. Not questioning dubious results can wreak havoc and unnecessarily flag high levels of impurities where none may exist, warned an official from Perrigo at a 31 August webinar.   The focus of the webinar, convened by the International Pharmaceutical Excipients Council (IPEC), focused on a set of best practic...
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    FDA declines to extend nitrosamine risk assessment deadline

    The US Food and Drug Administration (FDA) rejected pleas from the pharmaceutical industry to extend the deadline for conducting nitrosamine risk assessments to 1 September, standing firm on the 31 March deadline.   Industry representatives also told FDA to align its guidance with the International Council on Harmonization’s M7 guidance on impurity testing, saying  that divergent expectations have “created many challaneges for the pharmaceutical industry and increased ...
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    EMA updates Q&A on nitrosamine assessment and testing

    The European Medicines Agency (EMA) has published an updated “question and answer” guidance describing how manufacturers should assess the risk of nitrosamine impurities in drug products and how to test products for these impurities.   It contains minor revisions from a previous version published last year. (RELATED: EMA addresses risk evaluation, mitigation for nitrosamines , Regulatory Focus, 6 August 2020) . EMA wants marketing authorization holders (MAHs) ...
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    FDA studies: No post-ingestion NDMA from ranitidine

    An editorial that accompanied two recent studies examining the potential for nitrosamine formation from the antacid ranitidine welcomed reassuring news provided by the US Food and Drug Administration- (FDA-) led investigations.   The two FDA-led studies taken together “should serve to alleviate much of the previous concern about [ N -nitrosodimethylamine] production of dimethylamine drugs in the human body,” according to C. Michael White of the School of Pharmacy at th...