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Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's Perspective.
Sheean ME, Naumann-Winter F, Capovilla G, Kalland ME, Malikova E, Mariz S, Matusevicius D, Nistico R, Schwarzer-Daum B, Tsigkos S, Tzogani K, Larsson K, Magrelli A, Stoyanova-Beninska V. Sheean ME, et al. Among authors: naumann winter f. Front Med (Lausanne). 2021 Aug 27;8:744625. doi: 10.3389/fmed.2021.744625. eCollection 2021. Front Med (Lausanne). 2021. PMID: 34513895 Free PMC article.
Defining orphan conditions in the context of the European orphan regulation: challenges and evolution.
O'Connor DJ, Sheean ME, Hofer MP, Tsigkos S, Mariz S, Fregonese L, Larsson K, Hivert V, Westermark K, Naumann-Winter F, Stoyanova-Beninska V, Barišić I, Capovilla G, Magrelli A, Sepodes B. O'Connor DJ, et al. Among authors: naumann winter f. Nat Rev Drug Discov. 2019 Jul;18(7):479-480. doi: 10.1038/nrd.2018.128. Nat Rev Drug Discov. 2019. PMID: 30940922 No abstract available.
Assessment of significant benefit for orphan medicinal products by European regulators may support subsequent relative effectiveness assessments by health technology assessment organizations.
Vreman RA, de Ruijter AS, Zawada A, Tafuri G, Stoyanova-Beninska V, O'Connor D, Naumann-Winter F, Wolter F, Mantel-Teeuwisse AK, Leufkens HGM, Sidiropoulos I, Larsson K, Goettsch WG. Vreman RA, et al. Among authors: naumann winter f. Drug Discov Today. 2020 Jul;25(7):1223-1231. doi: 10.1016/j.drudis.2020.04.012. Epub 2020 Apr 25. Drug Discov Today. 2020. PMID: 32344040 Free article. Review.
Licensing of Orphan Medicinal Products-Use of Real-World Data and Other External Data on Efficacy Aspects in Marketing Authorization Applications Concluded at the European Medicines Agency Between 2019 and 2021.
Naumann-Winter F, Wolter F, Hermes U, Malikova E, Lilienthal N, Meier T, Kalland ME, Magrelli A. Naumann-Winter F, et al. Front Pharmacol. 2022 Aug 11;13:920336. doi: 10.3389/fphar.2022.920336. eCollection 2022. Front Pharmacol. 2022. PMID: 36034814 Free PMC article.
15 results