The influence of the European paediatric regulation on marketing authorisation of orphan drugs for children
Open Access
- 5 August 2014
- journal article
- Published by Springer Science and Business Media LLC in Orphanet Journal of Rare Diseases
- Vol. 9 (1), 120
- https://doi.org/10.1186/s13023-014-0120-x
Abstract
No abstract availableKeywords
This publication has 18 references indexed in Scilit:
- Pediatric requirements in Europe stymie help for hemophiliaNature Medicine, 2014
- European Union Pediatric Legislation Jeopardizes Worldwide, Timely Future Advances in the Care of Children With CancerClinical Therapeutics, 2014
- Drug reformulations and repositioning in the pharmaceutical industry and their impact on market access: regulatory implicationsJournal of Market Access & Health Policy, 2014
- Repurposing as a strategy for orphan drug development, evidence from European approvalsExpert Opinion on Orphan Drugs, 2013
- What the Orphan Drug Act Has Done Lately for Children With Rare Diseases: A 10-Year AnalysisPEDIATRICS, 2012
- The development of medicines for children: Part of a series on Pediatric Pharmacology, guest edited by Gianvincenzo Zuccotti, Emilio Clementi, and Massimo MolteniPharmacological Research, 2011
- Drug repositioning for orphan diseasesBriefings in Bioinformatics, 2011
- Database identifies FDA-approved drugs with potential to be repurposed for treatment of orphan diseasesBriefings in Bioinformatics, 2011
- Medicines for children licensed by the European Medicines Agency (EMEA): the balance after 10 yearsEuropean Journal of Clinical Pharmacology, 2006
- Survey of unlicensed and off label drug use in paediatric wards in European countriesBMJ, 2000