June 25, 2019

The holy grail of the pharma industry is FDA approval, but the final clue may be positive top-line (Phase III) results.  However, it is not out of the question that a Phase III study can meet its efficacy endpoint, yet still be rejected by the FDA.  This may especially...

October 18, 2018

Clinical holds are lost battles in the war against drug attrition.  The process of drug development critically revolves around the FDA’s Investigational New Drug (IND) application, which is the document required to start testing the drug in humans.  Any safety, efficac...

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