The outgoing US Food and Drug Administration (FDA) Commissioner Scott Gottlieb (pictured above) has called on other players in the drug development ecosystem to play their part in the modernization of clinical trials.
Dr Gottlieb sees the reform of trials as a priority for his agency and essential to the advance of precision medicine, with more diseases being redefined based on genomic subtype, researchers having more new targets and increasing opportunities to precisely modulate or even repair the basic biological drivers of illness.
Potential for earlier regulatory assessment
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