Nitrosamine Episode Could Lead To Paradigm Shift In Quality
Just How Well Do Companies Know Their Products?
The detection of cancer-causing impurities in drugs with well-established safety profiles may force regulators across the globe to revise their approach for evaluating quality.
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After EU regulators decided that biological medicines should be reviewed for the presence of possible nitrosamine impurities – as is already required for chemical medicines – new deadlines have been agreed on to give companies enough time to comply.
Following the US request for ranitidine drugs to be withdrawn from the market, the European Medicines Agency says it would decide the fate of the products in the EU after wrapping up its own inquiry.
Following the announcement in the US that ranitidine drugs must be withdrawn from the market, the European Medicines Agency told the Pink Sheet it would decide on the fate of these medicines in the EU after wrapping up its own inquiry.