Judith U Cope
Affiliation: Food and Drug Administration
- FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013Judith U Cope
Office of Pediatric Therapeutics, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, Silver Spring, Maryland and
Pediatrics 136:1125-31. 2015..This article follows a previous review ending in 2007 and summarizes 6 years of recent pediatric safety reporting, recommendations by the PAC, and actions by the FDA, including labeling changes...
- Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1-12 yearsJudith 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...
- Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse eventsJudith U Cope
Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, Maryland 20850, USA
Pediatrics 121:e1133-8. 2008....
- Emergency department visits for medical device-associated adverse events among childrenCunlin 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...
- Breast implant surveillance reports to the U.S. Food and Drug Administration: maternal-child health problemsS 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...
- Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007Rosemary Johann-Liang
Health Resources and Services Administration, Department of Health and Human Services, Rockville, MD 20857, USA
Pharmacoepidemiol Drug Saf 18:24-7. 2009....
- Device safety and effectiveness in the pediatric population: a US FDA perspectiveJoy 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...