EMA Confirms 'No Good' Stance On Omega-3 Drugs
The terms of the marketing authorizations for oral-use omega-3 fatty acid-containing medicines in the EU will have to updated to reflect the fact that they should no longer be used for secondary prevention after myocardial infarction.
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The European Medicines Agency is conducting safety reviews of Eliquis, Pradaxa and Xarelto, and is looking at whether the marketing authorization for the anticancer medicine Lartruvo should be maintained. It has also asked manufacturers of angiotensin II receptor blockers to review their manufacturing processes to ensure they do not produce nitrosamine impurities. Meanwhile, manufacturers of omega 3 fatty acid medicines have requested a re-examination of a CHMP recommendation on their products.
The UK is tightening its approach to enforcing best practices in clinical trial transparency.
The EU research-based pharma industry is exploring partnerships to develop an app that would extract data from the new Clinical Trial Information System and convert it into lay format to guide patients interested in participating in studies.