Shuren J - Search Results

1

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. Califf RM, et al. Among authors: shuren j. N Engl J Med. 2016 Dec 15;375(24):2395-2400. doi: 10.1056/NEJMsb1610128. N Engl J Med. 2016. PMID: 27974039 Free article. No abstract available.

2

The FDA and genetic testing.

Litwack ED, Mansfield E, Shuren J. Litwack ED, et al. Among authors: shuren j. N Engl J Med. 2015 Jun 4;372(23):2273-4. doi: 10.1056/NEJMc1504604. Epub 2015 May 27. N Engl J Med. 2015. PMID: 26014594 Free article. No abstract available.

3

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. Holmes DR Jr, et al. Among authors: shuren j. JACC Cardiovasc Interv. 2016 Mar 28;9(6):626-8. doi: 10.1016/j.jcin.2016.02.004. JACC Cardiovasc Interv. 2016. PMID: 27013168 Free article. No abstract available.

4

Need for a National Evaluation System for Health Technology.

Shuren J, Califf RM. Shuren J, et al. JAMA. 2016 Sep 20;316(11):1153-4. doi: 10.1001/jama.2016.8708. JAMA. 2016. PMID: 27398696 No abstract available.

5

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. Holmes DR Jr, et al. Among authors: shuren j. J Am Coll Cardiol. 2016 Oct 25;68(17):1908-1915. doi: 10.1016/j.jacc.2016.07.769. J Am Coll Cardiol. 2016. PMID: 27765194 Free article. Review.

6

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. Sherman RE, et al. Among authors: shuren j. N Engl J Med. 2016 Dec 8;375(23):2293-2297. doi: 10.1056/NEJMsb1609216. N Engl J Med. 2016. PMID: 27959688 No abstract available.

7

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

Faris O, Shuren J. Faris O, et al. Among authors: shuren j. N Engl J Med. 2017 Apr 6;376(14):1350-1357. doi: 10.1056/NEJMra1512592. N Engl J Med. 2017. PMID: 28379790 Free article. Review. No abstract available.

8

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

Fleurence RL, Blake K, Shuren J. Fleurence RL, et al. Among authors: shuren j. JAMA Cardiol. 2019 Mar 1;4(3):197-198. doi: 10.1001/jamacardio.2018.4933. JAMA Cardiol. 2019. PMID: 30785595 No abstract available.

9

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. Fleurence RL, et al. Among authors: shuren j. Clin Pharmacol Ther. 2019 Jul;106(1):30-33. doi: 10.1002/cpt.1380. Epub 2019 Mar 19. Clin Pharmacol Ther. 2019. PMID: 30888048 Free PMC article. No abstract available.

10

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

Fleurence RL, Forrest CB, Shuren J. Fleurence RL, et al. Among authors: shuren j. J Pediatr. 2019 Nov;214:209-211. doi: 10.1016/j.jpeds.2019.06.060. Epub 2019 Aug 1. J Pediatr. 2019. PMID: 31378521 Review. No abstract available.

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