EU OMBUDSMAN INCREASES PRESSURE ON EMA TO RELEASE DRUG ASSESSMENTS

BY KEITH NUTHALL THE EUROPEAN Ombudsman has made another demand that the European Medicines Agency (EMA) releases information about pharmaceuticals gathered during market approval assessments. P. Nikiforos Diamandouros has branded EMA guilty of maladministration when refusing Danish researchers access to clinical study reports and trial protocols for two anti-obesity drugs, not named in his ruling. The researchers wanted to conduct an independent analysis of their concerns about potential biased reporting on drug trials. EMA refused disclosure because it would ...


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