311 related articles for article (PubMed ID: 29280318)
1. Navigating Market Authorization: The Path Holoclar Took to Become the First Stem Cell Product Approved in the European Union.
Pellegrini G; Ardigò D; Milazzo G; Iotti G; Guatelli P; Pelosi D; De Luca M
Stem Cells Transl Med; 2018 Jan; 7(1):146-154. PubMed ID: 29280318
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. [Cell-based therapies - an innovative therapeutic option in ophthalmology: Treating corneal diseases with stem cells].
Bakker AC; Langer B
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2015 Nov; 58(11-12):1259-64. PubMed ID: 26459569
[TBL] [Abstract][Full Text] [Related]
5. [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]
6. From discovery to approval of an advanced therapy medicinal product-containing stem cells, in the EU.
Pellegrini G; Lambiase A; Macaluso C; Pocobelli A; Deng S; Cavallini GM; Esteki R; Rama P
Regen Med; 2016 Jun; 11(4):407-20. PubMed ID: 27091398
[TBL] [Abstract][Full Text] [Related]
7. Is Hospital Exemption an Alternative or a Bridge to European Medicines Agency for Developing Academic Chimeric Antigen Receptor T-Cell in Europe? Our Experience with ARI-0001.
Juan M; Delgado J; Calvo G; Trias E; Urbano-Ispizua Á
Hum Gene Ther; 2021 Oct; 32(19-20):1004-1007. PubMed ID: 34476985
[TBL] [Abstract][Full Text] [Related]
8. Use of the conditional marketing authorization pathway for oncology medicines in Europe.
Hoekman J; Boon WP; Bouvy JC; Ebbers HC; de Jong JP; De Bruin ML
Clin Pharmacol Ther; 2015 Nov; 98(5):534-41. PubMed ID: 26080745
[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. [Academic cell therapy facilities are challenged by European regulation on advanced therapy medicinal products].
Chabannon C; Sabatier F; Rial-Sebbag E; Calmels B; Veran J; Magalon G; Lemarie C; Mahalatchimy A
Med Sci (Paris); 2014 May; 30(5):576-83. PubMed ID: 24939546
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use.
Salmikangas P; Menezes-Ferreira M; Reischl I; Tsiftsoglou A; Kyselovic J; Borg JJ; Ruiz S; Flory E; Trouvin JH; Celis P; Ancans J; Timon M; Pante G; Sladowski D; Lipnik-Stangelj M; Schneider CK
Regen Med; 2015; 10(1):65-78. PubMed ID: 25562353
[TBL] [Abstract][Full Text] [Related]
13. Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.
Gomes KLG; da Silva RE; da Silva JB; Bosio CGP; Novaes MRCG
Cytotherapy; 2023 Oct; 25(10):1113-1123. PubMed ID: 37436339
[TBL] [Abstract][Full Text] [Related]
14. 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]
15. The European hospital exemption clause-new option for gene therapy?
Buchholz CJ; Sanzenbacher R; Schüle S
Hum Gene Ther; 2012 Jan; 23(1):7-12. PubMed ID: 22247961
[TBL] [Abstract][Full Text] [Related]
16. 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]
17. [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]
18. Factors affecting outcome following transplantation of ex vivo expanded limbal epithelium on amniotic membrane for total limbal deficiency in rabbits.
Ti SE; Anderson D; Touhami A; Kim C; Tseng SC
Invest Ophthalmol Vis Sci; 2002 Aug; 43(8):2584-92. PubMed ID: 12147589
[TBL] [Abstract][Full Text] [Related]
19. The hospital exemption pathway for the approval of advanced therapy medicinal products: an underused opportunity? The case of the CAR-T ARI-0001.
Trias E; Juan M; Urbano-Ispizua A; Calvo G
Bone Marrow Transplant; 2022 Feb; 57(2):156-159. PubMed ID: 35046545
[TBL] [Abstract][Full Text] [Related]
20. Corneal Epithelial Stem Cells Repopulate the Donor Area within 1 Year from Limbus Removal for Limbal Autograft.
Busin M; Breda C; Bertolin M; Bovone C; Ponzin D; Ferrari S; Barbaro V; Elbadawy HM
Ophthalmology; 2016 Dec; 123(12):2481-2488. PubMed ID: 27665215
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
