Pediatric Study Plans Would Be Required At End Of Phase II Under Bipartisan House Bill
This article was originally published in The Pink Sheet Daily
Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.
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Clinicians tell FDA that focusing solely on symptoms as an endpoint for pediatric ulcerative colitis and Crohn’s disease ignores the long-term deleterious effects of inflammation. Panel stresses the need to include growth as an endpoint and to conduct pediatric studies earlier.
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