These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
148 related articles for article (PubMed ID: 8960543)
1. Endovascular brachytherapy: the FDA's perspective. Ryan TA Int J Radiat Oncol Biol Phys; 1996 Nov; 36(4):992-3. PubMed ID: 8960543 [No Abstract] [Full Text] [Related]
2. Advisory committees" critical to the FDA's product review process. Rados C FDA Consum; 2004; 38(1):17-9. PubMed ID: 15032199 [No Abstract] [Full Text] [Related]
3. FDA perspective on clinical trial design for cardiovascular devices. Chen E; Sapirstein W; Ahn C; Swain J; Zuckerman B Ann Thorac Surg; 2006 Sep; 82(3):773-5. PubMed ID: 16928481 [No Abstract] [Full Text] [Related]
4. The FDA's role in medical device clinical studies of human subjects. Saviola J J Neural Eng; 2005 Mar; 2(1):S1-4. PubMed ID: 15876645 [TBL] [Abstract][Full Text] [Related]
5. An overview of FDA medical device regulation as it relates to deep brain stimulation devices. Peña C; Bowsher K; Costello A; De Luca R; Doll S; Li K; Schroeder M; Stevens T IEEE Trans Neural Syst Rehabil Eng; 2007 Sep; 15(3):421-4. PubMed ID: 17894274 [TBL] [Abstract][Full Text] [Related]
6. Benefit-Risk Assessments at the US Food and Drug Administration: Finding the Balance. Califf RM JAMA; 2017 Feb; 317(7):693-694. PubMed ID: 28114599 [No Abstract] [Full Text] [Related]
7. Bringing vascular brachytherapy to the US forefront: FDA approves two radiation systems for in-stent restenosis. Del Negro A Cardiovasc Radiat Med; 2001; 2(2):119-23. PubMed ID: 11340017 [No Abstract] [Full Text] [Related]
8. In the hot seat. Study questions FDA's fast-track process. McKinney M Mod Healthc; 2011 Feb; 41(8):16. PubMed ID: 21608192 [No Abstract] [Full Text] [Related]
9. Assessment of Clinical Trial Evidence for High-Risk Cardiovascular Devices Approved Under the Food and Drug Administration Priority Review Program. Jones LC; Dhruva SS; Redberg RF JAMA Intern Med; 2018 Oct; 178(10):1418-1420. PubMed ID: 30178044 [TBL] [Abstract][Full Text] [Related]
10. FDA approval of coronary-artery brachytherapy. Sapirstein W; Zuckerman B; Dillard J N Engl J Med; 2001 Jan; 344(4):297-9. PubMed ID: 11172159 [No Abstract] [Full Text] [Related]
11. The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling. Zimmerman M Br J Psychiatry; 2016 Jun; 208(6):512-4. PubMed ID: 27251690 [TBL] [Abstract][Full Text] [Related]
12. Not enough warning. GAO report finds FDA's medical device monitoring lacking. Hensley S Mod Healthc; 1997 Mar; 27(10):102, 104. PubMed ID: 10165267 [No Abstract] [Full Text] [Related]
13. FDA's new regulatory paradigms for in vitro diagnostic devices. Robinowitz M; Gutman SI Cytotherapy; 1999; 1(4):353-7. PubMed ID: 20426566 [No Abstract] [Full Text] [Related]
14. Cardiovascular device development: an FDA perspective. Zuckerman BD; Muni NI Am J Ther; 2005; 12(2):176-8. PubMed ID: 15767836 [No Abstract] [Full Text] [Related]
15. Two intravascular brachytherapy systems approved by FDA. SoRelle R Circulation; 2000 Nov; 102(21):E9041-3. PubMed ID: 11185473 [No Abstract] [Full Text] [Related]
17. Let the spin begin. Greater transparency urged for device trials. Becker C Mod Healthc; 2005 Mar; 35(11):33. PubMed ID: 15794228 [No Abstract] [Full Text] [Related]
18. The FDA's response to the GAO's report: new effort to tighten the pre-market review process for select Class III medical devices. Kim JH; Smith J; Greis J; Werling K Health Care Law Mon; 2009 May; 2009(5):2-8. PubMed ID: 19449776 [No Abstract] [Full Text] [Related]
19. The experience in the FDA's Center for Devices and Radiological Health with Bayesian strategies. Campbell G Clin Trials; 2005; 2(4):359-63; discussion 364-78. PubMed ID: 16281433 [No Abstract] [Full Text] [Related]
20. FDA's device inspection lacking. Two reports point to technology, staffing as key culprits. Rhea S Mod Healthc; 2008 Feb; 38(5):10-1. PubMed ID: 18318369 [No Abstract] [Full Text] [Related] [Next] [New Search]