U.S. & EU Pediatric Drug Regulators Strive For Dialogue, Not Harmonization
Though differences in timing and design of pediatric oncology trials within U.S. and Europe regulatory frameworks may make harmonization of trial requirements impossible, they should be seen as opportunities to expand understanding of drug development in the field, FDA said at an April 16 meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
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Future legislation should mandate increased public availability of pediatric trial data, Office of Pediatric Therapeutics Director Dianne Murphy said at a June 13 Institute of Medicine drug forum in Washington, D.C