Cargando…
Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs
OBJECTIVES: The research and development process in the field of rare diseases is characterised by many well-known difficulties, and a large percentage of orphan medicinal products do not reach the marketing approval. This work aims at identifying orphan medicinal products that failed the developmen...
Autores principales: | Giannuzzi, Viviana, Landi, Annalisa, Bosone, Enrico, Giannuzzi, Floriana, Nicotri, Stefano, Torrent-Farnell, Josep, Bonifazi, Fedele, Felisi, Mariagrazia, Bonifazi, Donato, Ceci, Adriana |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5595174/ https://www.ncbi.nlm.nih.gov/pubmed/28893754 http://dx.doi.org/10.1136/bmjopen-2017-017358 |
Ejemplares similares
-
Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen
por: Giannuzzi, Viviana, et al.
Publicado: (2017) -
Paediatric Medicines in Europe: The Paediatric Regulation—Is It Time for Reform?
por: Toma, Maddalena, et al.
Publicado: (2021) -
Target therapy for high-risk neuroblastoma treatment: integration of regulatory and scientific tools is needed
por: Ceci, Adriana, et al.
Publicado: (2023) -
Ethical and procedural issues for applying researcher-driven multi-national paediatric clinical trials in and outside the European Union: the challenging experience of the DEEP project
por: Giannuzzi, Viviana, et al.
Publicado: (2021) -
PedCRIN tool for the biosamples management in pediatric clinical trials
por: Giannuzzi, Viviana, et al.
Publicado: (2023)