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The European Medicines Agency is recommending that sponsors use clinical trial information from adults to support the development of therapies for children. Read More
The European Commission has granted orphan drug designation to fosbretabulin for the treatment of gastro-entero-pancreatic neuroendocrine tumors. Read More
In its second move this week to tackle the growing opioid epidemic, the FDA is outlining what tests sponsors of abuse-deterrent generic opioids should submit. Read More
The FDA’s plans to create a pilot database of clinical outcome assessments lacks the depth and breadth of data needed to make it worthwhile, according to comments from industry and advocacy groups. Read More