367 related articles for article (PubMed ID: 34711632)
41. Maximizing Regulatory Review Efficiency: The Evolution of the FDA OCE RTOR Pilot.
Gao YG; Roberts S; Guy A
Ther Innov Regul Sci; 2022 Mar; 56(2):212-219. PubMed ID: 35006588
[TBL] [Abstract][Full Text] [Related]
42. 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]
43. 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]
44. US Food and Drug Administration regulatory updates in neuro-oncology.
Mehta GU; Barone AK; Bradford D; Larkins E; Kim J; Pai-Scherf L; Jaigirdar A; Shah M; Wedam S; Amiri-Kordestani L; Theoret MR; Pazdur R; Beaver JA; Singh H
J Neurooncol; 2021 Jul; 153(3):375-381. PubMed ID: 34156585
[TBL] [Abstract][Full Text] [Related]
45. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021.
Benjamin DJ; Xu A; Lythgoe MP; Prasad V
JAMA Netw Open; 2022 Mar; 5(3):e222265. PubMed ID: 35289858
[TBL] [Abstract][Full Text] [Related]
46. Trends in the approval of cancer therapies by the FDA in the twenty-first century.
Scott EC; Baines AC; Gong Y; Moore R; Pamuk GE; Saber H; Subedee A; Thompson MD; Xiao W; Pazdur R; Rao VA; Schneider J; Beaver JA
Nat Rev Drug Discov; 2023 Aug; 22(8):625-640. PubMed ID: 37344568
[TBL] [Abstract][Full Text] [Related]
47. FDA Approvals of Oncology Drugs for Tissue-Agnostic Indications.
Zettler ME
Target Oncol; 2023 Sep; 18(5):777-792. PubMed ID: 37477750
[TBL] [Abstract][Full Text] [Related]
48. FDA approval summary: crizotinib for the treatment of metastatic non-small cell lung cancer with anaplastic lymphoma kinase rearrangements.
Kazandjian D; Blumenthal GM; Chen HY; He K; Patel M; Justice R; Keegan P; Pazdur R
Oncologist; 2014 Oct; 19(10):e5-11. PubMed ID: 25170012
[TBL] [Abstract][Full Text] [Related]
49. Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021.
Kandemir EA
J Oncol Pharm Pract; 2023 Jan; 29(1):191-207. PubMed ID: 35793068
[TBL] [Abstract][Full Text] [Related]
50. The response rate of alternative treatments for drugs approved on the basis of response rate.
Haslam A; Gill J; Prasad V
Int J Cancer; 2021 Feb; 148(3):713-722. PubMed ID: 32700797
[TBL] [Abstract][Full Text] [Related]
51. Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies.
Ladanie A; Speich B; Briel M; Sclafani F; Bucher HC; Agarwal A; Ioannidis JPA; Pereira TV; Kasenda B; Hemkens LG
J Clin Epidemiol; 2019 Oct; 114():49-59. PubMed ID: 31158450
[TBL] [Abstract][Full Text] [Related]
52. A fresh perspective on comparing the FDA and the CHMP/EMA: approval of antineoplastic tyrosine kinase inhibitors.
Shah RR; Roberts SA; Shah DR
Br J Clin Pharmacol; 2013 Sep; 76(3):396-411. PubMed ID: 23362829
[TBL] [Abstract][Full Text] [Related]
53. The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020.
Gloy V; Schmitt AM; Düblin P; Hirt J; Axfors C; Kuk H; Pereira TV; Locher C; Caquelin L; Walter-Claudi M; Lythgoe MP; Herbrand A; Kasenda B; Hemkens LG
Int J Cancer; 2023 Jun; 152(12):2474-2484. PubMed ID: 36779785
[TBL] [Abstract][Full Text] [Related]
54. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
[TBL] [Abstract][Full Text] [Related]
55. Median Survival or Mean Survival: Which Measure Is the Most Appropriate for Patients, Physicians, and Policymakers?
Ben-Aharon O; Magnezi R; Leshno M; Goldstein DA
Oncologist; 2019 Nov; 24(11):1469-1478. PubMed ID: 31320502
[TBL] [Abstract][Full Text] [Related]
56. In the end what matters most? A review of clinical endpoints in advanced breast cancer.
Verma S; McLeod D; Batist G; Robidoux A; Martins IR; Mackey JR
Oncologist; 2011; 16(1):25-35. PubMed ID: 21212428
[TBL] [Abstract][Full Text] [Related]
57. Correlation between progression-free survival and overall survival in metastatic breast cancer patients receiving anthracyclines, taxanes, or targeted therapies: a trial-level meta-analysis.
Adunlin G; Cyrus JW; Dranitsaris G
Breast Cancer Res Treat; 2015 Dec; 154(3):591-608. PubMed ID: 26596731
[TBL] [Abstract][Full Text] [Related]
58. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
Sumi E; Asada R; Lu Y; Ito-Ihara T; Grimes KV
Clin Ther; 2020 Feb; 42(2):305-320.e0. PubMed ID: 32008723
[TBL] [Abstract][Full Text] [Related]
59. Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide - Genta, G 3139, GC 3139, oblimersen sodium.
Drugs R D; 2007; 8(5):321-34. PubMed ID: 17767397
[TBL] [Abstract][Full Text] [Related]
60. FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin-Containing Chemotherapy.
Suzman DL; Agrawal S; Ning YM; Maher VE; Fernandes LL; Karuri S; Tang S; Sridhara R; Schroeder J; Goldberg KB; Ibrahim A; McKee AE; Pazdur R; Beaver JA
Oncologist; 2019 Apr; 24(4):563-569. PubMed ID: 30541754
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
