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Pediatric Cancer Study Requirements Added To FDA User Fee Bill

 
• By Sue Sutter

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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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.

The latest version of the FDA Reauthorization Act (FDARA) (H.R.2430) released July 10 would require pediatric studies for certain molecularly targeted cancer drugs.

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• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

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