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17 results
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Device safety and effectiveness in the pediatric population: a US FDA perspective.
Samuels-Reid J, Cope JU, Morrison AE. Samuels-Reid J, et al. Among authors: cope ju. Expert Rev Med Devices. 2009 Mar;6(2):131-5. doi: 10.1586/17434440.6.2.131. Expert Rev Med Devices. 2009. PMID: 19298160
Pediatric post-marketing safety systems in North America: assessment of the current status.
McMahon AW, Wharton GT, Bonnel R, DeCelle M, Swank K, Testoni D, Cope JU, Smith PB, Wu E, Murphy MD. McMahon AW, et al. Among authors: cope ju. Pharmacoepidemiol Drug Saf. 2015 Aug;24(8):785-92. doi: 10.1002/pds.3813. Epub 2015 Jun 22. Pharmacoepidemiol Drug Saf. 2015. PMID: 26098297 Review.
Medical devices and the pediatric population - a head-to-toe approach.
Samuels-Reid JH, Cope JU. Samuels-Reid JH, et al. Among authors: cope ju. Expert Rev Med Devices. 2019 Aug;16(8):647-652. doi: 10.1080/17434440.2019.1629285. Epub 2019 Jun 14. Expert Rev Med Devices. 2019. PMID: 31195845 Review.
FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.
Cope JU, Rosenthal GL, Weinel P, Odegaard A, Murphy DM. Cope JU, et al. Pediatrics. 2015 Dec;136(6):1125-31. doi: 10.1542/peds.2015-0469. Pediatrics. 2015. PMID: 26598453 Free article. Review.
Emergency department visits for medical device-associated adverse events among children.
Wang C, Hefflin B, Cope JU, Gross TP, Ritchie MB, Qi Y, Chu J. Wang C, et al. Among authors: cope ju. Pediatrics. 2010 Aug;126(2):247-59. doi: 10.1542/peds.2010-0528. Epub 2010 Jul 26. Pediatrics. 2010. PMID: 20660543
Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems.
Brown SL, Todd JF, Cope JU, Sachs HC. Brown SL, et al. Among authors: cope ju. J Long Term Eff Med Implants. 2006;16(4):281-90. doi: 10.1615/jlongtermeffmedimplants.v16.i4.20. J Long Term Eff Med Implants. 2006. PMID: 17073570
Medical Devices and Adolescents: Points to Consider.
Samuels-Reid JH, Cope JU. Samuels-Reid JH, et al. Among authors: cope ju. JAMA Pediatr. 2016 Nov 1;170(11):1035-1036. doi: 10.1001/jamapediatrics.2016.1351. JAMA Pediatr. 2016. PMID: 27618419 Free PMC article. No abstract available.
Pediatric devices and adverse events from A to Z: understanding the benefits and risks from a US FDA perspective.
Samuels-Reid J, Lawrence B, Millin C, Cope J. Samuels-Reid J, et al. Expert Rev Med Devices. 2012 May;9(3):275-82. doi: 10.1586/erd.12.7. Expert Rev Med Devices. 2012. PMID: 22702258 Review.
Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years.
Cope JU, Samuels-Reid JH, Morrison AE. Cope JU, et al. J Diabetes Sci Technol. 2012 Sep 1;6(5):1053-9. doi: 10.1177/193229681200600509. J Diabetes Sci Technol. 2012. PMID: 23063031 Free PMC article.
Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.
Cope JU, Morrison AE, Samuels-Reid J. Cope JU, et al. Pediatrics. 2008 May;121(5):e1133-8. doi: 10.1542/peds.2007-1707. Pediatrics. 2008. PMID: 18450857
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