292 related articles for article (PubMed ID: 27040338)
21. Devices, drugs, and the Food and Drug Administration: increasing implications for ischemic stroke.
Furlan AJ; Fisher M
Stroke; 2005 Feb; 36(2):398-9. PubMed ID: 15637320
[No Abstract] [Full Text] [Related]
22. [Medical devices approval process, a new French exception?].
Braillon A
Presse Med; 2011 Apr; 40(4 Pt 1):446-7. PubMed ID: 21334845
[No Abstract] [Full Text] [Related]
23. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
[TBL] [Abstract][Full Text] [Related]
24. Digital mammography. Why hasn't it been approved for U.S. hospitals?
Health Devices; 2000 Jan; 29(1):14-21. PubMed ID: 10631559
[TBL] [Abstract][Full Text] [Related]
25. 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]
26. Obstetric and gynecology devices; effective date of requirement for premarket approval for glans sheath devices. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2002 Jun; 67(115):40848-9. PubMed ID: 12068899
[TBL] [Abstract][Full Text] [Related]
27. Analytical Chemistry in the Regulatory Science of Medical Devices.
Wang Y; Guan A; Wickramasekara S; Phillips KS
Annu Rev Anal Chem (Palo Alto Calif); 2018 Jun; 11(1):307-327. PubMed ID: 29579404
[TBL] [Abstract][Full Text] [Related]
28. Medical devices; effective date of requirement for premarket approval for three preamendment class III devices. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Apr; 65(72):19833-4. PubMed ID: 11010634
[TBL] [Abstract][Full Text] [Related]
29. [Practice of Regulatory Science (Development of Medical Devices)].
Niimi S
Yakugaku Zasshi; 2017; 137(4):431-437. PubMed ID: 28381720
[TBL] [Abstract][Full Text] [Related]
30. Gastroenterology and urology devices; effective date of requirement for premarket approval of the implanted mechanical/hydraulic urinary continence device. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Sep; 65(187):57726-32. PubMed ID: 11503643
[TBL] [Abstract][Full Text] [Related]
31. Medical devices; gastroenterology-urology devices; classification of pancreatic drainage stent and delivery system. Final order.
Food and Drug Administration, HHS
Fed Regist; 2014 May; 79(103):30722-4. PubMed ID: 24873019
[TBL] [Abstract][Full Text] [Related]
32. Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.
Kesselheim AS
Clin Pharmacol Ther; 2010 Jun; 87(6):645-7. PubMed ID: 20485322
[TBL] [Abstract][Full Text] [Related]
33. Reforms of regulatory pathways for approval of new antineoplastic drugs in Japan from 2004 to 2019 and accompanying changes in pivotal clinical trial designs.
Hirai T; Suzuki A; Yamori T; Matsuura M
Invest New Drugs; 2022 Feb; 40(1):142-150. PubMed ID: 34417913
[TBL] [Abstract][Full Text] [Related]
34. Gastroenterology-urology devices; effective date of requirement for premarket approval of the penile inflatable implant. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Apr; 65(71):19650-8. PubMed ID: 11010632
[TBL] [Abstract][Full Text] [Related]
35. Pharmaceuticals and medical devices: FDA oversight. End-of-year issue brief.
Chaps NA
Issue Brief Health Policy Track Serv; 2010 Jan; ():1-31. PubMed ID: 20217914
[No Abstract] [Full Text] [Related]
36. Medical devices; gastroenterology-urology devices; nonimplanted, peripheral electrical continence device. Food and Drug Administration, HHS. Final rule.
Fed Regist; 2000 Apr; 65(68):18236-7. PubMed ID: 11010624
[TBL] [Abstract][Full Text] [Related]
37. Pharmaceuticals and medical devices: medical devices.
; Berry MD
Issue Brief Health Policy Track Serv; 2012 Jan; ():1-38. PubMed ID: 22403842
[No Abstract] [Full Text] [Related]
38. Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting.
Bonangelino P; Irony T; Liang S; Li X; Mukhi V; Ruan S; Xu Y; Yang X; Wang C
J Biopharm Stat; 2011 Sep; 21(5):938-53. PubMed ID: 21830924
[TBL] [Abstract][Full Text] [Related]
39. Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012.
Hwang J; Hwang TJ; Ciolino JB
BMJ Open; 2015 Jun; 5(6):e007987. PubMed ID: 26044760
[TBL] [Abstract][Full Text] [Related]
40. [New Medical Device Evaluation].
Ikeda K
Yakugaku Zasshi; 2016; 136(4):527-30. PubMed ID: 27040333
[TBL] [Abstract][Full Text] [Related]
[Previous] [Next] [New Search]
