CorrespondenceWill the revised class waiver list make it?
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Juvenile Testing to Support Clinical Trials in Pediatric Population
2024, A Comprehensive Guide to Toxicology in Nonclinical Drug DevelopmentFrom class waivers to precision medicine in paediatric oncology
2017, The Lancet OncologyCitation Excerpt :89 anticancer medicinal products have been class waivered over the past 3 years, and based on our analysis, 48 (54%) of these have a target or mechanism of action that might warrant paediatric development on the basis of existing molecular data, and were thus inappropriately granted a class waiver. The class waiver list has been repeatedly challenged over the past 8 years14,15 and the EMA and Paediatric Committee have made a continuous effort to improve the list. According to the most recent revision that was issued in July, 2015,8 only 12 (13%) of the 89 compounds that were initially class waivered would be kept on the list, and only one of them (1%; a thymidylate synthase inhibitor) was considered relevant in our analysis.
New Drugs for Rare Diseases in Children
2017, Clinical TherapeuticsCitation Excerpt :A good strategy to facilitate innovation in PO has not yet been evolved. What has evolved are attempts to force R&D of the research-based pharmaceutical industry to engage “more” in pediatric drug development.24,25 There are many reasons to expect that such attempts will not be successful, not the least of which is that most pediatric diseases, including cancer, differ profoundly from adult diseases.
Juvenile Toxicity Testing to Support Clinical Trials in Pediatric Population
2016, A Comprehensive Guide to Toxicology in Nonclinical Drug DevelopmentNew drugs for children with cancer: What needs to change in Europe
2016, Revue d'Oncologie Hematologie Pediatrique