Absence Of Pediatric Plans Put NDAs/BLAs At Risk For Refusal To File
Executive SummaryFDA may refuse to file drug applications that do not include a pediatric plan when sponsors ask for a deferral of pediatric data until after a drug is approved.
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Rather than assessing monetary penalties for violating study deadlines, H.R. 4274 directs FDA to issue warning letters and publish them on its website.