147 related articles for article (PubMed ID: 34450093)
1. Ensuring that accelerated approvals benefit patients.
The Lancet Haematology
Lancet Haematol; 2021 Sep; 8(9):e613. PubMed ID: 34450093
[No Abstract] [Full Text] [Related]
2. Beyond the Label: Ensuring That Drug Benefits Outweigh Risks in the Food and Drug Administration's Risk Evaluation and Mitigation Strategy Program.
Epstein MS; Shah ED; Deepak P; Kushnir VM
Am J Gastroenterol; 2019 Jul; 114(7):1017-1019. PubMed ID: 31033521
[No Abstract] [Full Text] [Related]
3. FDA's 'Accelerated Approvals' Are Critical But Raise Thorny Issues.
Miller HI
Mo Med; 2019; 116(3):168-169. PubMed ID: 31527930
[No Abstract] [Full Text] [Related]
4. Evaluating the safety of diabetes drugs: perspective of a Food and Drug Administration insider.
Misbin RI
Diabetes Care; 2005 Oct; 28(10):2573-6. PubMed ID: 16186303
[No Abstract] [Full Text] [Related]
5. The US Food and Drug Administration's use of regular approval for cancer drugs based on single-arm studies: implications for subsequent evidence generation.
DeLoughery EP; Prasad V
Ann Oncol; 2018 Mar; 29(3):527-529. PubMed ID: 29346605
[No Abstract] [Full Text] [Related]
6. Two-stage drug approval would reduce the risks.
Frantz JA
Nature; 2005 May; 435(7039):143. PubMed ID: 15889063
[No Abstract] [Full Text] [Related]
7. Accelerated approvals under the microscope.
Mullard A
Nat Rev Drug Discov; 2021 Jun; 20(6):409-411. PubMed ID: 34012001
[No Abstract] [Full Text] [Related]
8. 2015 FDA drug approvals.
Mullard A
Nat Rev Drug Discov; 2016 Feb; 15(2):73-6. PubMed ID: 26837582
[No Abstract] [Full Text] [Related]
9. How European regulators view foreign data in the approval process.
Breckenridge A; Hudson I
Clin Pharmacol Ther; 2008 Sep; 84(3):311-2. PubMed ID: 18714321
[TBL] [Abstract][Full Text] [Related]
10. Oncology 2020: a drug development and approval paradigm.
Dhingra K
Ann Oncol; 2015 Nov; 26(11):2347-50. PubMed ID: 26374285
[No Abstract] [Full Text] [Related]
11. End points and United States Food and Drug Administration approval of oncology drugs.
Johnson JR; Williams G; Pazdur R
J Clin Oncol; 2003 Apr; 21(7):1404-11. PubMed ID: 12663734
[TBL] [Abstract][Full Text] [Related]
12. The FDA's generic-drug approval process: similarities to and differences from brand-name drugs.
Kefalas CH; Ciociola AA
Am J Gastroenterol; 2011 Jun; 106(6):1018-21. PubMed ID: 21637264
[No Abstract] [Full Text] [Related]
13. Carvedilol and the Food and Drug Administration approval process: an introduction.
Fisher LD; Moyé LA
Control Clin Trials; 1999 Feb; 20(1):1-15. PubMed ID: 10027497
[TBL] [Abstract][Full Text] [Related]
14. FDA new drug approvals in Q3 2019.
Urquhart L
Nat Rev Drug Discov; 2019 Oct; 18(11):816. PubMed ID: 31673140
[No Abstract] [Full Text] [Related]
15. Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Green DJ; Sun H; Burnham J; Liu XI; van den Anker J; Temeck J; Yao L; McCune SK; Burckart GJ
Clin Pharmacol Ther; 2019 Mar; 105(3):555-557. PubMed ID: 30094815
[TBL] [Abstract][Full Text] [Related]
16. Drug safety special: the safety catch.
Wadman M
Nature; 2005 Mar; 434(7033):554-6. PubMed ID: 15800591
[No Abstract] [Full Text] [Related]
17. 2010 FDA drug approvals.
Mullard A
Nat Rev Drug Discov; 2011 Feb; 10(2):82-5. PubMed ID: 21283092
[No Abstract] [Full Text] [Related]
18. Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.
Ribeiro TB; Buss L; Wayant C; Nobre MRC
PLoS One; 2020; 15(7):e0236345. PubMed ID: 32706800
[TBL] [Abstract][Full Text] [Related]
19. Stakeholders discuss biosimilar naming, substitution.
Traynor K
Am J Health Syst Pharm; 2014 Mar; 71(6):446-7. PubMed ID: 24589534
[No Abstract] [Full Text] [Related]
20. Inappropriate use of progression-free survival in cancer drug approvals.
Naci H; Davis C
BMJ; 2020 Mar; 368():m770. PubMed ID: 32156802
[No Abstract] [Full Text] [Related]
[Next] [New Search]