One third of the drugs approved by the FDA and the EMA have a high therapeutic value
In a retrospective analysis recently published in the British Medical Journal, it was observed that a third of the drugs […]
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FDA accept ‘Priority Review’ for lurbinectedin in small-cell lung cancer
PharmaMar and Jazz Pharmaceuticals have just announced that the American regulatory agency FDA has accepted the Priority Review of lurbinectedin […]
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Approved a new Royal Decree that reinforces control over homeopathic drugs.
The new amendment to Royal Decree 1345/2007 includes, among other changes, the obligation to conduct clinical trials with homeopathic drugs with therapeutic indications.
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AEMPS issues an update of instructions for conducting clinical trials
New instructions define more precisely the process for the notification of serious and unexpected adverse reactions in clinical trials.
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The European registry of clinical trials is expected to be accessible by 2020
The European Medicines Agency will launch a European registry of clinical trials in 2020, which will complement existing registries.
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