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Items: 1 to 20 of 45

1.

Strengthening the Evidence Base for Pediatric Medical Devices Using Real-World Data.

Fleurence RL, Forrest CB, Shuren J.

J Pediatr. 2019 Nov;214:209-211. doi: 10.1016/j.jpeds.2019.06.060. Epub 2019 Aug 1. No abstract available.

PMID:
31378521
2.

Advances in the Use of Real-World Evidence for Medical Devices: An Update From the National Evaluation System for Health Technology.

Fleurence RL, Shuren J.

Clin Pharmacol Ther. 2019 Jul;106(1):30-33. doi: 10.1002/cpt.1380. Epub 2019 Mar 19. No abstract available.

3.

The Future of Registries in the Era of Real-world Evidence for Medical Devices.

Fleurence RL, Blake K, Shuren J.

JAMA Cardiol. 2019 Mar 1;4(3):197-198. doi: 10.1001/jamacardio.2018.4933. No abstract available.

PMID:
30785595
4.

The 21st Century Cures Act and Early Feasibility Studies for Cardiovascular Devices: What Have We Learned, Where Do We Need to Go?

Holmes DR Jr, Hance R, Syrek Jensen TS, Schwartz DA, Kaplan A, Farb A, Zuckerman B, Leon M, Waklowiak J, Mack MJ, Shuren J.

JACC Cardiovasc Interv. 2018 Nov 12;11(21):2220-2225. doi: 10.1016/j.jcin.2018.05.010. Review.

5.

FDA Regulation of Mobile Medical Apps.

Shuren J, Patel B, Gottlieb S.

JAMA. 2018 Jul 24;320(4):337-338. doi: 10.1001/jama.2018.8832. No abstract available.

PMID:
29971339
6.

An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials.

Faris O, Shuren J.

N Engl J Med. 2017 Apr 6;376(14):1350-1357. doi: 10.1056/NEJMra1512592. Review. No abstract available.

7.

Transforming Evidence Generation to Support Health and Health Care Decisions.

Califf RM, Robb MA, Bindman AB, Briggs JP, Collins FS, Conway PH, Coster TS, Cunningham FE, De Lew N, DeSalvo KB, Dymek C, Dzau VJ, Fleurence RL, Frank RG, Gaziano JM, Kaufmann P, Lauer M, Marks PW, McGinnis JM, Richards C, Selby JV, Shulkin DJ, Shuren J, Slavitt AM, Smith SR, Washington BV, White PJ, Woodcock J, Woodson J, Sherman RE.

N Engl J Med. 2016 Dec 15;375(24):2395-2400. No abstract available.

8.

Real-World Evidence - What Is It and What Can It Tell Us?

Sherman RE, Anderson SA, Dal Pan GJ, Gray GW, Gross T, Hunter NL, LaVange L, Marinac-Dabic D, Marks PW, Robb MA, Shuren J, Temple R, Woodcock J, Yue LQ, Califf RM.

N Engl J Med. 2016 Dec 8;375(23):2293-2297. No abstract available.

PMID:
27959688
9.

Overcoming the Challenges of Conducting Early Feasibility Studies of Medical Devices in the United States.

Holmes DR Jr, Califf R, Farb A, Abel D, Mack M, Syrek Jensen T, Zuckerman B, Leon M, Shuren J.

J Am Coll Cardiol. 2016 Oct 25;68(17):1908-1915. doi: 10.1016/j.jacc.2016.07.769. Review.

10.

Need for a National Evaluation System for Health Technology.

Shuren J, Califf RM.

JAMA. 2016 Sep 20;316(11):1153-4. doi: 10.1001/jama.2016.8708. No abstract available.

PMID:
27398696
11.

Clinical Perspective--Early Feasibility Device Medical Studies in the United States: Time for More Than Regulatory Reform.

Holmes DR Jr, Shuren J, Califf R, Zuckerman B, Abel D, Farb A, Leon M, Mack M.

JACC Cardiovasc Interv. 2016 Mar 28;9(6):626-8. doi: 10.1016/j.jcin.2016.02.004. No abstract available.

12.

Shuren Says Patients Are 'The Heart' of CDRH Focus.

Shuren J.

Biomed Instrum Technol. 2015 Sep-Oct;49(5):338-44. doi: 10.2345/0899-8205-49.5.338. No abstract available.

PMID:
26443910
13.

Reduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective.

Laschinger JC, Wu C, Ibrahim NG, Shuren JE.

N Engl J Med. 2015 Nov 19;373(21):1996-8. doi: 10.1056/NEJMp1512264. Epub 2015 Oct 5. No abstract available.

14.

The FDA and genetic testing.

Litwack ED, Mansfield E, Shuren J.

N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27. No abstract available.

15.

Transcatheter valve therapy registry is a model for medical device innovation and surveillance.

Carroll JD, Shuren J, Jensen TS, Hernandez J, Holmes D, Marinac-Dabic D, Edwards FH, Zuckerman BD, Wood LL, Kuntz RE, Mack MJ.

Health Aff (Millwood). 2015 Feb;34(2):328-34. doi: 10.1377/hlthaff.2014.1010.

PMID:
25646114
16.

The FDA's role in the development of medical mobile applications.

Shuren J.

Clin Pharmacol Ther. 2014 May;95(5):485-8. doi: 10.1038/clpt.2014.45.

PMID:
24747239
17.

Modernizing device regulation.

Kretzer RM, Foreman CL, Shuren J.

N Engl J Med. 2010 Jul 8;363(2):196-7; author reply 197. No abstract available.

PMID:
20653080
18.

Asymmetrical involvement of frontal lobes in social reasoning.

Goel V, Shuren J, Sheesley L, Grafman J.

Brain. 2004 Apr;127(Pt 4):783-90. Epub 2004 Feb 19.

PMID:
14976069
19.

The neurology of reasoning.

Shuren JE, Grafman J.

Arch Neurol. 2002 Jun;59(6):916-9. Review. No abstract available.

PMID:
12056926
20.

Direct sale of sildenafil (Viagra) to consumers over the Internet.

Henney JE, Shuren JE.

N Engl J Med. 2000 Mar 9;342(10):740, 742. No abstract available.

PMID:
10712127

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