Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties

Abstract Background To assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice. Methods...

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Bibliographic Details
Main Authors: Caridad Pontes, Juan Manuel Fontanet, Roser Vives, Aranzazu Sancho, Mònica Gómez-Valent, José Ríos, Rosa Morros, Jorge Martinalbo, Martin Posch, Armin Koch, Kit Roes, Katrien Oude Rengerink, Josep Torrent-Farnell, Ferran Torres
Format: Article
Language:English
Published: BMC 2018-11-01
Series:Orphanet Journal of Rare Diseases
Subjects:
Orphan drug production
Rare diseases
Research design/methods
Research design/standards
Clinical trials as topic
Drug approval
Online Access:http://link.springer.com/article/10.1186/s13023-018-0926-z

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http://link.springer.com/article/10.1186/s13023-018-0926-z

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