Pediatric Oncology Advances Could Prompt More FDA-Required Studies
Findings being presented at ASCO next month could signify major increase in targets relevant to pediatric oncology, meaning sponsors should prepare for more US FDA-required studies under the RACE for Children legislation.
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Agency urged to prioritize studies based on strength of preclinical and adult data, and good mechanistic understanding of how multiple therapies are expected to work together; new pediatric study requirements for molecularly targeted agents take effect in August 2020.
ASCO official argues postmarket development of diagnostics may restrict patient use once added to the label.
Beginning in August 2020, applications for some novel cancer drugs and biologics will have to include reports on molecularly targeted pediatric investigations; agency is already working with sponsors on pediatric study development plans and expects to issue two draft guidances soon.