In addition to deciding to suspend ranitidine-containing medicines, the European Medicines Agency has issued recommendations on testing patients for DPD deficiency before they are treated with fluorouracil or related medicines.
Ranitidine medicines are being suspended in the EU due to the presence of the nitrosamine impurity, N-nitrosodimethylamine (NDMA).
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Recognizing that the evidence it receives in applications for health technology assessments will increasingly be informed by artificial intelligence, the CDA-AMC has clarified its expectations for companies that use AI methods in the generation and/or reporting of evidence.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.
