374 related articles for article (PubMed ID: 29574211)
1. EU decision-making for marketing authorization of advanced therapy medicinal products: a case study.
de Wilde S; Coppens DGM; Hoekman J; de Bruin ML; Leufkens HGM; Guchelaar HJ; Meij P
Drug Discov Today; 2018 Jul; 23(7):1328-1333. PubMed ID: 29574211
[TBL] [Abstract][Full Text] [Related]
2. A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making.
Coppens DGM; de Wilde S; Guchelaar HJ; De Bruin ML; Leufkens HGM; Meij P; Hoekman J
Cytotherapy; 2018 Jun; 20(6):769-778. PubMed ID: 29730080
[TBL] [Abstract][Full Text] [Related]
3. Comparison of regulatory pathways for the approval of advanced therapies in the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A
Cytotherapy; 2021 Mar; 23(3):261-274. PubMed ID: 33483292
[TBL] [Abstract][Full Text] [Related]
4. [Safety monitoring of cell-based medicinal products (CBMPs)].
Funk MB; Frech M; Spranger R; Keller-Stanislawski B
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1239-46. PubMed ID: 26391098
[TBL] [Abstract][Full Text] [Related]
5. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT Perspective.
Salmikangas P; Schuessler-Lenz M; Ruiz S; Celis P; Reischl I; Menezes-Ferreira M; Flory E; Renner M; Ferry N
Adv Exp Med Biol; 2015; 871():103-30. PubMed ID: 26374215
[TBL] [Abstract][Full Text] [Related]
6. Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.
Fürst-Ladani S; Bührer A; Fürst W; Schober-Ladani N
Handb Exp Pharmacol; 2024; 284():367-387. PubMed ID: 37017789
[TBL] [Abstract][Full Text] [Related]
7. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
[TBL] [Abstract][Full Text] [Related]
8. Hurdles in clinical implementation of academic advanced therapy medicinal products: A national evaluation.
de Wilde S; Veltrop-Duits L; Hoozemans-Strik M; Ras T; Blom-Veenman J; Guchelaar HJ; Zandvliet M; Meij P
Cytotherapy; 2016 Jun; 18(6):797-805. PubMed ID: 27068764
[TBL] [Abstract][Full Text] [Related]
9. Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe.
Farkas AM; Mariz S; Stoyanova-Beninska V; Celis P; Vamvakas S; Larsson K; Sepodes B
Front Med (Lausanne); 2017; 4():53. PubMed ID: 28560211
[TBL] [Abstract][Full Text] [Related]
10. [The certification of advanced therapy medicinal products. A quality label for product development in small and medium-sized enterprises].
Berger A; Schüle S; Flory E
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2011 Jul; 54(7):816-21. PubMed ID: 21698534
[TBL] [Abstract][Full Text] [Related]
11. Marketing Regulatory Oversight of Advanced Therapy Medicinal Products in Europe.
Schuessler-Lenz M; Herberts C; Reischl I; Ruiz S; Celis P; Beuneu C; Kjeken R; Timón M
Adv Exp Med Biol; 2023; 1430():1-21. PubMed ID: 37526839
[TBL] [Abstract][Full Text] [Related]
12. Patient access to and ethical considerations of the application of the European Union hospital exemption rule for advanced therapy medicinal products.
Cuende N; Ciccocioppo R; Forte M; Galipeau J; Ikonomou L; Levine BL; Srivastava A; Zettler PJ
Cytotherapy; 2022 Jul; 24(7):686-690. PubMed ID: 35545453
[TBL] [Abstract][Full Text] [Related]
13. [The use of nanotechnology in medicinal products in the light of European Union law].
Jurewicz M
Pol Merkur Lekarski; 2014 Dec; 37(222):369-72. PubMed ID: 25715580
[TBL] [Abstract][Full Text] [Related]
14. A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA.
Dalla Torre Di Sanguinetto S; Heinonen E; Antonov J; Bolte C
Ther Innov Regul Sci; 2019 Jan; 53(1):86-94. PubMed ID: 29714594
[TBL] [Abstract][Full Text] [Related]
15. Regulatory watch: Where do new medicines originate from in the EU?
Lincker H; Ziogas C; Carr M; Porta N; Eichler HG
Nat Rev Drug Discov; 2014 Feb; 13(2):92-3. PubMed ID: 24481298
[No Abstract] [Full Text] [Related]
16. Hurdles of environmental risk assessment procedures for advanced therapy medicinal products: comparison between the European Union and the United States.
Iglesias-Lopez C; Obach M; Vallano A; Agustí A; Montané J
Crit Rev Toxicol; 2019 Aug; 49(7):580-596. PubMed ID: 31846383
[TBL] [Abstract][Full Text] [Related]
17. Ethical considerations in orphan drug approval and use.
Kesselheim AS
Clin Pharmacol Ther; 2012 Aug; 92(2):153-5. PubMed ID: 22814660
[TBL] [Abstract][Full Text] [Related]
18. A Worldwide Overview of Regulatory Frameworks for Tissue-Based Products.
Oberweis CV; Marchal JA; López-Ruiz E; Gálvez-Martín P
Tissue Eng Part B Rev; 2020 Apr; 26(2):181-196. PubMed ID: 31910099
[TBL] [Abstract][Full Text] [Related]
19. Establishing rarity in the context of orphan medicinal product designation in the European Union.
Tsigkos S; Hofer MP; Sheean ME; Mariz S; Larsson K; Naumann-Winter F; Fregonese L; Sepodes B
Drug Discov Today; 2018 Mar; 23(3):681-686. PubMed ID: 28647377
[TBL] [Abstract][Full Text] [Related]
20. Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance.
Permanand G; Mossialos E; McKee M
Clin Med (Lond); 2006; 6(1):87-90. PubMed ID: 16521363
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]