Did pediatric drug development advance epilepsy treatment in young patients? It is time for new research goals

Table 1 Key events in the tension between pediatric drug development and epilepsy clinical research

Ref.	Year	Event
[23]	1950	Toxicities are reported in preterm newborns treated with antibiotics
[17]	1962	United States pharmaceutical legislation (Keifauver-Harris Amendment)
[23]	1968	Shirkey coins the term “therapeutic orphans“
[8,30]	1996	United States National Institutes of Health “pediatric“ antiseizure medications workshop in Bethesda, MD, United States
[32]	1997	United States pediatric legislation
[13]	2006	European Union pediatric legislation
[80]	2010	European Medicines claims fundamental difference in pediatric vs adult epilepsy, demands studies in > 100 children for new drugs
[7]	2012	Efficacy of antiseizure medications in adults predicts efficacy in minors
[22]	2016	Proposal for a new paradigm
[8]	2017	Proof that antiseizure medications work both in adults and minors
[11]	2018	Justification of “pediatric drug development“ repeated
[20]	2019	Food and Drug Administration accepts extrapolation for antiseizure medications adults to minors
[80]	2019	European Medicines authors equate antiseizure medications approval with "availability," as if without approval they would not exist for patients before their 18th birthday
[81]	2023	EMA accepts extrapolation from adults to “children“