Judith U Cope

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. pmc Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years
    Judith U Cope
    Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Diabetes Sci Technol 6:1053-9. 2012
  2. doi request reprint Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events
    Judith U Cope
    Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, Maryland 20850, USA
    Pediatrics 121:e1133-8. 2008
  3. doi request reprint Emergency department visits for medical device-associated adverse events among children
    Cunlin Wang
    Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Silver Spring, MD 20993 0002, USA
    Pediatrics 126:247-59. 2010
  4. ncbi request reprint Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems
    S Lori Brown
    Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health Food and Drug Administration, Seattle District Office, Bothell, WA 98021 4421, USA
    J Long Term Eff Med Implants 16:281-90. 2006
  5. doi request reprint Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007
    Rosemary Johann-Liang
    Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 18:24-7. 2009
  6. doi request reprint Device safety and effectiveness in the pediatric population: a US FDA perspective
    Joy Samuels-Reid
    Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health, Office of Device Evaluation, FDA, Rockville, MD 20857, USA
    Expert Rev Med Devices 6:131-5. 2009

Detail Information

Publications6

  1. pmc Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 years
    Judith U Cope
    Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland 20993, USA
    J Diabetes Sci Technol 6:1053-9. 2012
    ..S. Food and Drug Administration (FDA) for children ages 1-12 years...
  2. doi request reprint Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events
    Judith U Cope
    Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, Maryland 20850, USA
    Pediatrics 121:e1133-8. 2008
    ....
  3. doi request reprint Emergency department visits for medical device-associated adverse events among children
    Cunlin Wang
    Food and Drug Administration, Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Silver Spring, MD 20993 0002, USA
    Pediatrics 126:247-59. 2010
    ..The purposes of this study were to provide national estimates of emergency department (ED) visits for medical device-associated adverse events (MDAEs) in the pediatric population and to characterize these events further...
  4. ncbi request reprint Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problems
    S Lori Brown
    Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health Food and Drug Administration, Seattle District Office, Bothell, WA 98021 4421, USA
    J Long Term Eff Med Implants 16:281-90. 2006
    ..An additional 3.5% of reports (n=12) detailed a congenital anomaly believed by the reporter to be caused by breast implants...
  5. doi request reprint Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007
    Rosemary Johann-Liang
    Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD 20857, USA
    Pharmacoepidemiol Drug Saf 18:24-7. 2009
    ....
  6. doi request reprint Device safety and effectiveness in the pediatric population: a US FDA perspective
    Joy Samuels-Reid
    Division of Anesthesiology, General Hospital, Infection Control and Dental Devices, Center for Devices and Radiological Health, Office of Device Evaluation, FDA, Rockville, MD 20857, USA
    Expert Rev Med Devices 6:131-5. 2009
    ..Risk mitigation may also differ, and heightened awareness will reduce the potential for adverse events and promote the safe use of medical devices in children...