A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

por Kashoki, Mwango, Hanaizi, Zahra, Yordanova, Stella, Veselý, Richard, Bouygues, Christelle, Llinares, Jordi, Kweder, Sandra L.
Publicado 2019

Establishing medical plausibility in the context of orphan medicines designation in the European Union

por Tsigkos, Stelios, Mariz, Segundo, Llinares, Jordi, Fregonese, Laura, Aarum, Stiina, Frauke, Naumann-Winter, Westermark, Kerstin, Sepodes, Bruno
Publicado 2014

Erratum to: Establishing medical plausibility in the context of orphan medicines designation in the European Union

por Tsigkos, Stelios, Mariz, Segundo, Llinares, Jordi, Fregonese, Laura, Aarum, Stiina, Naumann-Winter, Frauke, Westermark, Kerstin, Sepodes, Bruno
Publicado 2015

Use of biomarkers in the context of orphan medicines designation in the European Union

por Tsigkos, Stelios, Llinares, Jordi, Mariz, Segundo, Aarum, Stiina, Fregonese, Laura, Dembowska-Baginska, Bozenna, Elbers, Rembert, Evers, Pauline, Foltanova, Tatiana, Lhoir, Andre, Corrêa-Nunes, Ana, O’Connor, Daniel, Voordouw, Albertha, Westermark, Kerstin, Sepodes, Bruno
Publicado 2014