213 related articles for article (PubMed ID: 33877088)
21. Priority review drugs approved by the FDA and the EMA: time for international regulatory harmonization of pharmaceuticals?
Alqahtani S; Seoane-Vazquez E; Rodriguez-Monguio R; Eguale T
Pharmacoepidemiol Drug Saf; 2015 Jul; 24(7):709-15. PubMed ID: 26013294
[TBL] [Abstract][Full Text] [Related]
22. Added benefit and revenues of oncology drugs approved by the European Medicines Agency between 1995 and 2020: retrospective cohort study.
Brinkhuis F; Goettsch WG; Mantel-Teeuwisse AK; Bloem LT
BMJ; 2024 Feb; 384():e077391. PubMed ID: 38418086
[TBL] [Abstract][Full Text] [Related]
23. ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.
Poveda JL; Gómez C; Gil A; Badia X
Orphanet J Rare Dis; 2023 Jan; 18(1):4. PubMed ID: 36609401
[TBL] [Abstract][Full Text] [Related]
24. [Analysis of the evolution in the access to orphan medicines in Spain].
Mestre-Ferrándiz J; Iniesta M; Trapero-Bertran M; Espín J; Brosa M
Gac Sanit; 2020; 34(2):141-149. PubMed ID: 31014554
[TBL] [Abstract][Full Text] [Related]
25. Agreement about Availability of Alternative Treatments for Innovative Drugs Assessed by the EMA and HTA Organizations.
Madrid Paredes J; Versteeg JW; Vreman RA; Bloem LT
Clin Pharmacol Ther; 2024 Jul; 116(1):136-146. PubMed ID: 38505926
[TBL] [Abstract][Full Text] [Related]
26. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
[TBL] [Abstract][Full Text] [Related]
27. 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]
28. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
Kühler TC; Bujar M; McAuslane N; Liberti L
BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
[TBL] [Abstract][Full Text] [Related]
29. Review and comparison of clinical evidence submitted to support European Medicines Agency market authorization of orphan-designated oncological treatments.
Winstone J; Chadda S; Ralston S; Sajosi P
Orphanet J Rare Dis; 2015 Oct; 10():139. PubMed ID: 26511061
[TBL] [Abstract][Full Text] [Related]
30. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
Cherla A; Naci H; Kesselheim AS; Gyawali B; Mossialos E
JAMA Intern Med; 2021 Apr; 181(4):490-498. PubMed ID: 33616607
[TBL] [Abstract][Full Text] [Related]
31. Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs.
Giannuzzi V; Landi A; Bosone E; Giannuzzi F; Nicotri S; Torrent-Farnell J; Bonifazi F; Felisi M; Bonifazi D; Ceci A
BMJ Open; 2017 Sep; 7(9):e017358. PubMed ID: 28893754
[TBL] [Abstract][Full Text] [Related]
32. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].
Enzmann H; Broich K
Z Evid Fortbild Qual Gesundhwes; 2013; 107(2):120-8. PubMed ID: 23663906
[TBL] [Abstract][Full Text] [Related]
33. Effectiveness, safety and costs of orphan drugs: an evidence-based review.
Onakpoya IJ; Spencer EA; Thompson MJ; Heneghan CJ
BMJ Open; 2015 Jun; 5(6):e007199. PubMed ID: 26109112
[TBL] [Abstract][Full Text] [Related]
34. Registering medicines for low-income countries: how suitable are the stringent review procedures of the World Health Organisation, the US Food and Drug Administration and the European Medicines Agency?
Doua JY; Van Geertruyden JP
Trop Med Int Health; 2014 Jan; 19(1):23-36. PubMed ID: 24134396
[TBL] [Abstract][Full Text] [Related]
35. 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]
36. New trends and challenges in the European regulation of innovative medicines.
Enzmann H
Regul Toxicol Pharmacol; 2016 Oct; 80():314-20. PubMed ID: 27237379
[TBL] [Abstract][Full Text] [Related]
37. Clinical evidence supporting the marketing authorization of biosimilars in Europe.
Allocati E; Bertele' V; Gerardi C; Garattini S; Banzi R
Eur J Clin Pharmacol; 2020 Apr; 76(4):557-566. PubMed ID: 31897530
[TBL] [Abstract][Full Text] [Related]
38. The characteristics and regulations of adaptive designs from 2008 to 2020: An overview of European Medicines Agency approvals.
Huang X; Ma J; Lu Z; Huang L
Int J Clin Pharmacol Ther; 2023 Oct; 61(10):445-454. PubMed ID: 37548455
[TBL] [Abstract][Full Text] [Related]
39. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.
Zeitoun JD; Lefèvre JH; Downing NS; Bergeron H; Ross JS
Br J Clin Pharmacol; 2015 Oct; 80(4):716-26. PubMed ID: 25808713
[TBL] [Abstract][Full Text] [Related]
40. The Evaluation of Drug Innovativeness in Italy: Key Determinants and Internal Consistency.
Jommi C; Galeone C
Pharmacoecon Open; 2023 May; 7(3):373-381. PubMed ID: 36763319
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]