214 related articles for article (PubMed ID: 36780147)
21. Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.
Skydel JJ; Egilman AC; Wallach JD; Ramachandran R; Gupta R; Ross JS
JAMA Health Forum; 2022 May; 3(5):e221158. PubMed ID: 35977252
[TBL] [Abstract][Full Text] [Related]
22. Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?
Rivera VM
Neurol Ther; 2019 Dec; 8(2):177-184. PubMed ID: 31313222
[TBL] [Abstract][Full Text] [Related]
23. An international comparative analysis of public reimbursement of orphan drugs in Canadian provinces compared to European countries.
Ward LM; Chambers A; Mechichi E; Wong-Rieger D; Campbell C
Orphanet J Rare Dis; 2022 Mar; 17(1):113. PubMed ID: 35246200
[TBL] [Abstract][Full Text] [Related]
24. 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]
25. Marketing authorisation and pricing of FDA-approved cancer drugs in Brazil: a retrospective analysis.
Ivama-Brummell AM; Marciniuk FL; Wagner AK; Osorio-de-Castro CGS; Vogler S; Mossialos E; Tavares-de-Andrade CL; Naci H
Lancet Reg Health Am; 2023 Jun; 22():100506. PubMed ID: 37235087
[TBL] [Abstract][Full Text] [Related]
26. How Data Packages Lacking Phase III Pivotal Trial Data Can Support Regulatory Approval and Reimbursement for Oncologics in Australia.
Macaulay R; Siddiqui MK; Stoddart S
Value Health Reg Issues; 2015 May; 6():143-149. PubMed ID: 29698188
[TBL] [Abstract][Full Text] [Related]
27. Reimbursement of Orphan Drugs in Europe in Relation to the Type of Authorization by the European Medicines Agency and the Decision Making Based on Health Technology Assessment.
Malinowski KP; Kawalec P; Trabka W; Sowada C; Pilc A
Front Pharmacol; 2018; 9():1263. PubMed ID: 30483124
[No Abstract] [Full Text] [Related]
28. The association between US Food and Drug Administration-expedited review designations and health plan specialty drug coverage.
Panzer AD; Ingham M; Martin S; Chambers JD
J Manag Care Spec Pharm; 2023 May; 29(5):464-471. PubMed ID: 36989444
[No Abstract] [Full Text] [Related]
29. Iodine-131 Tositumomab: (131)I-anti-B1 antibody, (131)I-tositumomab, anti-CD20 murine monoclonal antibody-I-131, B1, Bexxar, (131)I-anti-B1 antibody, iodine-131 tositumomab, iodine-131 anti-B1 antibody, tositumomab.
BioDrugs; 2003; 17(4):290-5. PubMed ID: 12899647
[TBL] [Abstract][Full Text] [Related]
30. Common drug review recommendations for orphan drugs in Canada: basis of recommendations and comparison with similar reviews in Quebec, Australia, Scotland and New Zealand.
McCormick JI; Berescu LD; Tadros N
Orphanet J Rare Dis; 2018 Jan; 13(1):27. PubMed ID: 29382371
[TBL] [Abstract][Full Text] [Related]
31. Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.
Michaeli DT; Michaeli T; Albers S; Boch T; Michaeli JC
Eur J Health Econ; 2023 Nov; ():. PubMed ID: 37962724
[TBL] [Abstract][Full Text] [Related]
32. Efaproxiral: GSJ 61, JP 4, KDD 86, RS 4, RSR 13.
Drugs R D; 2005; 6(3):178-85. PubMed ID: 15869322
[TBL] [Abstract][Full Text] [Related]
33. FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
Darrow JJ; Avorn J; Kesselheim AS
JAMA; 2020 Jan; 323(2):164-176. PubMed ID: 31935033
[TBL] [Abstract][Full Text] [Related]
34. The reimbursement decision speed for oncology new drugs in China and its determinant factors.
Zhu X; Chen Y
Front Public Health; 2023; 11():1207739. PubMed ID: 38026304
[TBL] [Abstract][Full Text] [Related]
35. 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]
36. Health technology assessment and reimbursement policy for oncology orphan drugs in Central and Eastern Europe.
Malinowski KP; Kawalec P; Trąbka W; Sowada C; Petrova G; Manova M; Savova A; Draganić P; Slabý J; Männik A; Márky K; Rugaja Z; Gulbinovic J; Tesar T; Paveliu MS
Orphanet J Rare Dis; 2020 Oct; 15(1):277. PubMed ID: 33032634
[TBL] [Abstract][Full Text] [Related]
37. Application of orphan drug designation to cancer treatments (2008-2017): a comprehensive and comparative analysis of the USA and EU.
Vokinger KN; Kesselheim AS
BMJ Open; 2019 Oct; 9(10):e028634. PubMed ID: 31601584
[TBL] [Abstract][Full Text] [Related]
38. FDA approval, clinical trial evidence, efficacy, epidemiology, and price for non-orphan and ultra-rare, rare, and common orphan cancer drug indications: cross sectional analysis.
Michaeli T; Jürges H; Michaeli DT
BMJ; 2023 May; 381():e073242. PubMed ID: 37160306
[TBL] [Abstract][Full Text] [Related]
39. A Time-Trend Economic Analysis of Cancer Drug Trials.
Cressman S; Browman GP; Hoch JS; Kovacic L; Peacock SJ
Oncologist; 2015 Jul; 20(7):729-36. PubMed ID: 26032135
[TBL] [Abstract][Full Text] [Related]
40. The FDA Unapproved Drugs Initiative: An Observational Study of the Consequences for Drug Prices and Shortages in the United States.
Gupta R; Dhruva SS; Fox ER; Ross JS
J Manag Care Spec Pharm; 2017 Oct; 23(10):1066-1076. PubMed ID: 28944731
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
