Biopharma companies would get a three-year grace period before new US pediatric cancer study requirements kick in under FDA user fee legislation expected to come up for a House vote this week.
Pediatric Cancer Study Requirements Added To FDA User Fee Bill
User fee legislation headed for a US House vote this week would require pediatric studies of certain molecularly targeted cancer drugs; the requirement, which could apply to some orphan drugs, would not take effect for three years.
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