Full Pediatric Labeling Is Lacking For One Third Of Orphan Drugs, US FDA Finds
The past three years have seen an increase in number of orphan drug labels containing appropriate pediatric information.
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The former US FDA principal deputy commissioner argues that accelerated approval, fast track and breakthrough designation standards may need updating, along with orphan and pediatric exclusivity requirements, to enhance the programs' efficacy.
PhRMA asks FDA to consider expiration of pediatric exclusivity in requesting pediatric clinical trials; AbbVie describes eight-year effort to begin enrollment in Humira pediatric ulcerative colitis study.
Even in the grip of the pandemic, review times for priority drugs were also consistent with the last three years.