156 related articles for article (PubMed ID: 36682367)
1. Impact of the EU Paediatric Medicine Regulation on new anti-cancer medicines for the treatment of children and adolescents.
Vassal G; de Rojas T; Pearson ADJ
Lancet Child Adolesc Health; 2023 Mar; 7(3):214-222. PubMed ID: 36682367
[TBL] [Abstract][Full Text] [Related]
2. Delays in completion and results reporting of clinical trials under the Paediatric Regulation in the European Union: A cohort study.
Hwang TJ; Tomasi PA; Bourgeois FT
PLoS Med; 2018 Mar; 15(3):e1002520. PubMed ID: 29494592
[TBL] [Abstract][Full Text] [Related]
3. Orphan Drug Regulation: A missed opportunity for children and adolescents with cancer.
Vassal G; Kearns P; Blanc P; Scobie N; Heenen D; Pearson A
Eur J Cancer; 2017 Oct; 84():149-158. PubMed ID: 28818704
[TBL] [Abstract][Full Text] [Related]
4. The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children.
Kreeftmeijer-Vegter AR; de Boer A; van der Vlugt-Meijer RH; de Vries PJ
Orphanet J Rare Dis; 2014 Aug; 9():120. PubMed ID: 25091201
[TBL] [Abstract][Full Text] [Related]
5. Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products.
Ceci A; Felisi M; Catapano M; Baiardi P; Cipollina L; Ravera S; Bagnulo S; Reggio S; Rondini G
Eur J Clin Pharmacol; 2002 Nov; 58(8):495-500. PubMed ID: 12451425
[TBL] [Abstract][Full Text] [Related]
6. Comparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designations.
Ecker A; Mariz S; Naumann-Winter F; Norga K; Barisic I; Girard T; Tomasi P; Mentzer D; Sepodes B
Arch Dis Child; 2018 May; 103(5):427-430. PubMed ID: 29089318
[TBL] [Abstract][Full Text] [Related]
7. Marketing authorisations for unmet medical needs: A critical appraisal of regulatory pathways in the European Union.
Manellari S; Musazzi UM; Rocco P; Minghetti P
Int J Pharm; 2023 Jul; 642():123193. PubMed ID: 37394157
[TBL] [Abstract][Full Text] [Related]
8. More medicines for children: impact of the EU paediatric regulation.
Nordenmalm S; Tomasi P; Pallidis C
Arch Dis Child; 2018 Jun; 103(6):557-564. PubMed ID: 29490933
[TBL] [Abstract][Full Text] [Related]
9. The EU paediatric regulation: still a large discrepancy between therapeutic needs and approved paediatric investigation plans.
Wimmer S; Rascher W; McCarthy S; Neubert A
Paediatr Drugs; 2014 Oct; 16(5):397-406. PubMed ID: 25056717
[TBL] [Abstract][Full Text] [Related]
10. Creating a unique, multi-stakeholder Paediatric Oncology Platform to improve drug development for children and adolescents with cancer.
Vassal G; Rousseau R; Blanc P; Moreno L; Bode G; Schwoch S; Schrappe M; Skolnik J; Bergman L; Bradley-Garelik MB; Saha V; Pearson A; Zwierzina H
Eur J Cancer; 2015 Jan; 51(2):218-24. PubMed ID: 25434924
[TBL] [Abstract][Full Text] [Related]
11. Successful private-public funding of paediatric medicines research: lessons from the EU programme to fund research into off-patent medicines.
Ruggieri L; Giannuzzi V; Baiardi P; Bonifazi F; Davies EH; Giaquinto C; Bonifazi D; Felisi M; Chiron C; Pressler R; Rabe H; Whitaker MJ; Neubert A; Jacqz-Aigrain E; Eichler I; Turner MA; Ceci A;
Eur J Pediatr; 2015 Apr; 174(4):481-91. PubMed ID: 25241827
[TBL] [Abstract][Full Text] [Related]
12. Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation.
Tomasi PA; Egger GF; Pallidis C; Saint-Raymond A
Paediatr Drugs; 2017 Dec; 19(6):505-513. PubMed ID: 28900869
[TBL] [Abstract][Full Text] [Related]
13. Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies: ACCELERATE in collaboration with the European Medicines Agency with the participation of the Food and Drug Administration.
Pearson ADJ; Barry E; Mossé YP; Ligas F; Bird N; de Rojas T; Zimmerman ZF; Wilner K; Woessmann W; Weiner S; Weigel B; Venkatramani R; Valteau D; Trahair T; Smith M; Singh S; Selvaggi G; Scobie N; Schleiermacher G; Richardson N; Park J; Nysom K; Norga K; Merino M; McDonough J; Matloub Y; Marshall LV; Lowe E; Lesa G; Irwin M; Karres D; Gajjar A; Doz F; Fox E; DuBois SG; Donoghue M; Casanova M; Caron H; Buenger V; Bradford D; Blanc P; Barone A; Reaman G; Vassal G
Eur J Cancer; 2021 Nov; 157():198-213. PubMed ID: 34536944
[TBL] [Abstract][Full Text] [Related]
14. Orphan Medicines for Pediatric Use: A Focus on the European Union.
Bolislis WR; Corriol-Rohou S; Hill-Venning C; Hoogland H; Joos A; King D; Kitcatt V; Le Visage G; Kühler TC
Clin Ther; 2019 Dec; 41(12):2630-2642. PubMed ID: 31704041
[TBL] [Abstract][Full Text] [Related]
15. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].
Enzmann H; Broich K
Z Evid Fortbild Qual Gesundhwes; 2013; 107(2):120-8. PubMed ID: 23663906
[TBL] [Abstract][Full Text] [Related]
16. Market access to new anticancer medicines for children and adolescents with cancer in Europe.
Schoot RA; Otth MA; Frederix GWJ; Leufkens HGM; Vassal G
Eur J Cancer; 2022 Apr; 165():146-153. PubMed ID: 35235871
[TBL] [Abstract][Full Text] [Related]
17. Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD; Stegmaier K; Bourdeaut F; Reaman G; Heenen D; Meyers ML; Armstrong SA; Brown P; De Carvalho D; Jabado N; Marshall L; Rivera M; Smith M; Adamson PC; Barone A; Baumann C; Blackman S; Buenger V; Donoghue M; Duncan AD; Fox E; Gadbaw B; Hattersley M; Ho P; Jacobs I; Kelly MJ; Kieran M; Lesa G; Ligas F; Ludwinski D; McDonough J; Nikolova Z; Norga K; Senderowicz A; Taube T; Weiner S; Karres D; Vassal G
Eur J Cancer; 2020 Nov; 139():135-148. PubMed ID: 32992153
[TBL] [Abstract][Full Text] [Related]
18. Paediatric Strategy Forum for medicinal product development of chimeric antigen receptor T-cells in children and adolescents with cancer: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration.
Pearson AD; Rossig C; Mackall C; Shah NN; Baruchel A; Reaman G; Ricafort R; Heenen D; Bassan A; Berntgen M; Bird N; Bleickardt E; Bouchkouj N; Bross P; Brownstein C; Cohen SB; de Rojas T; Ehrlich L; Fox E; Gottschalk S; Hanssens L; Hawkins DS; Horak ID; Taylor DH; Johnson C; Karres D; Ligas F; Ludwinski D; Mamonkin M; Marshall L; Masouleh BK; Matloub Y; Maude S; McDonough J; Minard-Colin V; Norga K; Nysom K; Pappo A; Pearce L; Pieters R; Pule M; Quintás-Cardama A; Richardson N; Schüßler-Lenz M; Scobie N; Sersch MA; Smith MA; Sterba J; Tasian SK; Weigel B; Weiner SL; Zwaan CM; Lesa G; Vassal G
Eur J Cancer; 2022 Jan; 160():112-133. PubMed ID: 34840026
[TBL] [Abstract][Full Text] [Related]
19. Three years of paediatric regulation in the European Union.
Olski TM; Lampus SF; Gherarducci G; Saint Raymond A
Eur J Clin Pharmacol; 2011 Mar; 67(3):245-52. PubMed ID: 21286912
[TBL] [Abstract][Full Text] [Related]
20. Paediatric Medicines in Europe: The Paediatric Regulation-Is It Time for Reform?
Toma M; Felisi M; Bonifazi D; Bonifazi F; Giannuzzi V; Reggiardo G; de Wildt S; Ceci A;
Front Med (Lausanne); 2021; 8():593281. PubMed ID: 33604345
[No Abstract] [Full Text] [Related]
[Next] [New Search]