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Home » FDA Issues Guidance for Including Targeted Oncology Drugs in Pediatrics
FDA Issues Guidance for Including Targeted Oncology Drugs in Pediatrics
A new FDA draft guidance for sponsors developing cancer drugs would require NDAs and BLAs submitted after Aug. 18, 2020, that present a new active ingredient to include reports of molecularly targeted pediatric cancer investigations unless a deferral or waiver is granted by the FDA.