FDA ODAC wants two confirmatory studies for early approvals, with plans before OK
This article was originally published in Scrip
If a panel of advisers to the US FDA has its way, makers of cancer drugs that receive accelerated approval, other than paediatric or rare disease oncology medicines, will be required to conduct at least two adequate and well-controlled trials to confirm the clinical benefit of their products, with regulators signing off on those study plans before that expedited OK is granted.
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