Major Inquiry Into EMA Pre-Submission Meetings And Bias Risk Concludes
The European Ombudsman has recommended how the European Medicines Agency can avoid even the perception that the decisions it takes on marketing authorization applications are influenced by the pre-submission interactions it has with drug developers.
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An inquiry by the EU Ombudsman has prompted the European Medicines Agency to introduce changes to ensure that its experts, who advise companies in the premarket phase, are not appointed to evaluate marketing applications for the same drugs.
The European Medicines Agency’s practice of holding pre-submission meetings with drug developers is being investigated by the European Ombudsman, who believes there is scope to make such interactions more transparent to tackle concerns over possible bias.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include five new products, including Lumoxiti, AstraZeneca's drug for hairy cell leukemia. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).