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US FDA Should Reassess Postmarket Trials for Cancer Drugs Approved via Accelerated Pathway, Researchers Say (30-05-2019)

Boston, Massachusetts, 28 May 2019: The US Food and Drug Administration (FDA) may need to reassess how confirmatory trials are conducted after just one-fifth of such trials for cancer drug indications approved via FDA’s accelerated approval pathway have demonstrated improve......
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Source : Regulatory Focus

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