EMA To Update Active Substances Guide To Address Nitrosamine Contamination
The European Medicines Agency wants to make it clearer for drug sponsors what more they can do to address the presence of cancer-causing impurities in active substances, and how to deal with the issue in their regulatory submissions.
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Regulators in the EU have decided on specific arrangements they plan to employ if sponsors detect and report nitrosamine impurities in their products being sold on the market.
A full appraisal by the UK cost watchdog is not the only way to gauge the safety and effectiveness of Evusheld, argues the independent Drug Safety Research Unit in response to the government’s decision not to buy the licensed COVID-19 drug because of insufficient data on protection.
EU regulators have developed a draft good practice guide explaining how stakeholders can make use of the Metadata Catalog of RWD Sources, which is expected to be released in late 2023, to identify appropriate sources for specific research questions.