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...

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Detalhes bibliográficos
Publicado no:BMJ Open
Main Authors: Giannuzzi, Viviana, Landi, Annalisa, Bosone, Enrico, Giannuzzi, Floriana, Nicotri, Stefano, Torrent-Farnell, Josep, Bonifazi, Fedele, Felisi, Mariagrazia, Bonifazi, Donato, Ceci, Adriana
Formato: Artigo
Idioma:Inglês
Publicado em: BMJ Publishing Group 2017
Assuntos:
Pharmacology and Therapeutics
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC5595174/
https://ncbi.nlm.nih.gov/pubmed/28893754
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2017-017358
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