MIT News – Artificial intelligence Before a drug is approved by the U.S. Food and Drug Administration (FDA), it must demonstrate both safety and efficacy. However, the FDA does not require an understanding a drug’s mechanism of action for approval. This acceptance of results without explanation raises the question of whether the “black box” decision-making […]Continue reading

Danish Medicines Agency Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions […]Continue reading

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