Pediatric Cancer Studies: US FDA Promises Flexible Approach On Requirements
Executive Summary
FDA says it will not be 'held hostage' by its list of molecular targets, but patient advocates worry agency will be deterred from requiring assessments for targets not on the list, while industry worries about being surprised by demands for pediatric data.
You may also be interested in...
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.
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.
Oncology Sponsors Getting A Jump On Pediatric Study Requirements, US FDA Says
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests:
