235 related articles for article (PubMed ID: 32199487)
1. Generating comparative evidence on new drugs and devices after approval.
Cipriani A; Ioannidis JPA; Rothwell PM; Glasziou P; Li T; Hernandez AF; Tomlinson A; Simes J; Naci H
Lancet; 2020 Mar; 395(10228):998-1010. PubMed ID: 32199487
[TBL] [Abstract][Full Text] [Related]
2. Generating comparative evidence on new drugs and devices before approval.
Naci H; Salcher-Konrad M; Kesselheim AS; Wieseler B; Rochaix L; Redberg RF; Salanti G; Jackson E; Garner S; Stroup TS; Cipriani A
Lancet; 2020 Mar; 395(10228):986-997. PubMed ID: 32199486
[TBL] [Abstract][Full Text] [Related]
3. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
4. Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and the USA: a systematic analysis of 10 devices based on Austrian pre-reimbursement assessments.
Wild C; Erdös J; Zechmeister I
BMC Cardiovasc Disord; 2014 Nov; 14():154. PubMed ID: 25366498
[TBL] [Abstract][Full Text] [Related]
5. The US Food and Drug Administration's expedited approval programs: Evidentiary standards, regulatory trade-offs, and potential improvements.
Wallach JD; Ross JS; Naci H
Clin Trials; 2018 Jun; 15(3):219-229. PubMed ID: 29871509
[TBL] [Abstract][Full Text] [Related]
6. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.
Reeve LM
Regul Toxicol Pharmacol; 2009 Nov; 55(2):181-7. PubMed ID: 19589365
[TBL] [Abstract][Full Text] [Related]
7. Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.
Warner JJ; Crook HL; Whelan KM; Bleser WK; Roiland RA; Hamilton Lopez M; Saunders RS; Wang TY; Hernandez AF; McClellan MB; Califf RM; Brown N;
Circ Cardiovasc Qual Outcomes; 2020 Jul; 13(7):e006606. PubMed ID: 32683985
[TBL] [Abstract][Full Text] [Related]
8. Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process.
Heneghan CJ; Goldacre B; Onakpoya I; Aronson JK; Jefferson T; Pluddemann A; Mahtani KR
BMJ Open; 2017 Dec; 7(12):e017125. PubMed ID: 29212782
[TBL] [Abstract][Full Text] [Related]
9. The future of Cochrane Neonatal.
Soll RF; Ovelman C; McGuire W
Early Hum Dev; 2020 Nov; 150():105191. PubMed ID: 33036834
[TBL] [Abstract][Full Text] [Related]
10. Preventing postmarketing changes in recommended doses and marketing withdrawals.
Peck C
Ernst Schering Res Found Workshop; 2007; (59):209-16. PubMed ID: 17117726
[TBL] [Abstract][Full Text] [Related]
11. Improving medical device regulation: the United States and Europe in perspective.
Sorenson C; Drummond M
Milbank Q; 2014 Mar; 92(1):114-50. PubMed ID: 24597558
[TBL] [Abstract][Full Text] [Related]
12. Proposed study designs for approval based on a surrogate endpoint and a post-marketing confirmatory study under FDA's accelerated approval regulations for disease modifying osteoarthritis drugs.
Kraus VB; Simon LS; Katz JN; Neogi T; Hunter D; Guermazi A; Karsdal MA
Osteoarthritis Cartilage; 2019 Apr; 27(4):571-579. PubMed ID: 30465809
[TBL] [Abstract][Full Text] [Related]
13. Impact of Postapproval Evidence Generation on the Biopharmaceutical Industry.
Milne CP; Cohen JP; Felix A; Chakravarthy R
Clin Ther; 2015 Aug; 37(8):1852-8. PubMed ID: 26143223
[TBL] [Abstract][Full Text] [Related]
14. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
Rathi VK; Krumholz HM; Masoudi FA; Ross JS
JAMA; 2015 Aug; 314(6):604-12. PubMed ID: 26262798
[TBL] [Abstract][Full Text] [Related]
15. Gaps, tensions, and conflicts in the FDA approval process: implications for clinical practice.
Deyo RA
J Am Board Fam Pract; 2004; 17(2):142-9. PubMed ID: 15082674
[TBL] [Abstract][Full Text] [Related]
16. New Drug Postmarketing Requirements and Commitments in the US: A Systematic Review of the Evidence.
Moneer O; Brown BL; Avorn J; Darrow JJ; Mitra-Majumdar M; Joyce KW; Ross M; Pham C; Kesselheim AS
Drug Saf; 2022 Apr; 45(4):305-318. PubMed ID: 35182362
[TBL] [Abstract][Full Text] [Related]
17. 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]
18. Post-approval Studies for Rare Disease Treatments and Orphan Drugs.
Maier WC; Christensen RA; Anderson P
Adv Exp Med Biol; 2017; 1031():197-205. PubMed ID: 29214573
[TBL] [Abstract][Full Text] [Related]
19. FDA marketing claims, and the practitioner.
Runner S
J Evid Based Dent Pract; 2006 Mar; 6(1):19-23. PubMed ID: 17138391
[TBL] [Abstract][Full Text] [Related]
20. Guidelines, editors, pharma and the biological paradigm shift.
Singh AR; Singh SA
Mens Sana Monogr; 2007 Jan; 5(1):27-30. PubMed ID: 22058616
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
