Robert P Wise

Summary

Affiliation: Food and Drug Administration
Country: USA

Publications

  1. ncbi request reprint Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine
    Robert P Wise
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 292:1702-10. 2004
  2. doi request reprint Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008
    Emily Jane Woo
    Food and Drug Administration, FDA CBER OBE, Rockville, MD 20852, USA
    Vaccine 29:1319-23. 2011
  3. ncbi request reprint Anaphylactoid reactions to Dextran 40 and 70: reports to the United States Food and Drug Administration, 1969 to 2004
    Craig E Zinderman
    Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, MD 20852, USA
    J Vasc Surg 43:1004-9. 2006
  4. ncbi request reprint Adverse events reported following live, cold-adapted, intranasal influenza vaccine
    Hector S Izurieta
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 294:2720-5. 2005
  5. ncbi request reprint Pediatric deaths reported after vaccination: the utility of information obtained from parents
    Linda E Silvers
    U S Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA
    Am J Prev Med 22:170-6. 2002
  6. ncbi request reprint Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulin
    Robert P Wise
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852 1448, USA
    Pharmacoepidemiol Drug Saf 11:651-4. 2002
  7. doi request reprint Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010
    Tarun K Mallick
    Office of Biostatistics and Epidemiology, FDA CBER, 1401 Rockville Pike, Suite 400 S, Rockville, MD 20852, USA
    Cell Tissue Bank 13:259-67. 2012
  8. ncbi request reprint Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety data
    Robert P Wise
    Food and Drug Administration, Rockville, MD, USA
    Vaccine 25:5717-24. 2007
  9. ncbi request reprint Thromboembolic adverse events after use of recombinant human coagulation factor VIIa
    Kathryn A O'Connell
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 295:293-8. 2006
  10. doi request reprint Babesia infection through blood transfusions: reports received by the US Food and Drug Administration, 1997-2007
    Diane M Gubernot
    Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852 1448, USA
    Clin Infect Dis 48:25-30. 2009

Collaborators

Detail Information

Publications20

  1. ncbi request reprint Postlicensure safety surveillance for 7-valent pneumococcal conjugate vaccine
    Robert P Wise
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 292:1702-10. 2004
    ..Clinical trials evaluate a vaccine's safety before approval, but some risks may escape detection or adequate characterization until larger population exposures occur after licensure...
  2. doi request reprint Thrombocytopenia after vaccination: case reports to the US Vaccine Adverse Event Reporting System, 1990-2008
    Emily Jane Woo
    Food and Drug Administration, FDA CBER OBE, Rockville, MD 20852, USA
    Vaccine 29:1319-23. 2011
    ..TP was reported after inactivated and live viral vaccines. Platelet counts <10×10(9)/L were reported. Identified vaccines could be prioritized for hypothesis-testing studies...
  3. ncbi request reprint Anaphylactoid reactions to Dextran 40 and 70: reports to the United States Food and Drug Administration, 1969 to 2004
    Craig E Zinderman
    Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, MD 20852, USA
    J Vasc Surg 43:1004-9. 2006
    ..The objective of the study was to describe the frequency and characteristics of reports submitted to the United States Food and Drug Administration (FDA) for anaphylaxis or anaphylactoid events after clinical dextran administration...
  4. ncbi request reprint Adverse events reported following live, cold-adapted, intranasal influenza vaccine
    Hector S Izurieta
    Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 294:2720-5. 2005
    ..Although prelicensure testing involved 20 228 vaccinees, clinical trials were not of sufficient size to detect rare adverse events reliably...
  5. ncbi request reprint Pediatric deaths reported after vaccination: the utility of information obtained from parents
    Linda E Silvers
    U S Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Biostatistics and Epidemiology, Rockville, Maryland 20855, USA
    Am J Prev Med 22:170-6. 2002
    ..This investigation explored whether routinely interviewing parents for follow-up of VAERS pediatric deaths would provide additional information important to vaccine safety...
  6. ncbi request reprint Pharmacoepidemiologic implications of erroneous varicella vaccinations in pregnancy through confusion with Varicella zoster immune globulin
    Robert P Wise
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research CBER, Food and Drug Administration FDA, 1401 Rockville Pike, Rockville, MD 20852 1448, USA
    Pharmacoepidemiol Drug Saf 11:651-4. 2002
    ..Periodic reassessments of selected preventable problems might strengthen efforts to minimize product risks...
  7. doi request reprint Reported infections after human tissue transplantation before and after new Food and Drug Administration (FDA) regulations, United States, 2001 through June, 2010
    Tarun K Mallick
    Office of Biostatistics and Epidemiology, FDA CBER, 1401 Rockville Pike, Suite 400 S, Rockville, MD 20852, USA
    Cell Tissue Bank 13:259-67. 2012
    ..However, these data do not confirm that the reported infections were caused by suspect tissues; most reports may represent routine post-surgical infections not actually due to allografts...
  8. ncbi request reprint Thrombocytopenia: case definition and guidelines for collection, analysis, and presentation of immunization safety data
    Robert P Wise
    Food and Drug Administration, Rockville, MD, USA
    Vaccine 25:5717-24. 2007
  9. ncbi request reprint Thromboembolic adverse events after use of recombinant human coagulation factor VIIa
    Kathryn A O'Connell
    Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, MD 20852 1448, USA
    JAMA 295:293-8. 2006
    ..Use in patients without hemophilia has been increasing since licensure...
  10. doi request reprint Babesia infection through blood transfusions: reports received by the US Food and Drug Administration, 1997-2007
    Diane M Gubernot
    Office of Blood Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, Maryland 20852 1448, USA
    Clin Infect Dis 48:25-30. 2009
    ..Babesia infection is a transfusion-transmissable disease. An estimated 70 cases were reported during 1979-2007; most of these cases were reported during the past decade...
  11. doi request reprint Assessment of tissue allograft safety monitoring with administrative healthcare databases: a pilot project using Medicare data
    Sanjaya Dhakal
    Division of Epidemiology DE, Office of Biostatistics and Epidemiology OBE, Center for Biologics Evaluation and Research CBER, Food and Drug Administration, 1401 Rockville Pike WOC I 441 S, Rockville, MD, 20852, USA
    Cell Tissue Bank 15:75-84. 2014
    ....
  12. ncbi request reprint Polyarteritis nodosa reports to the vaccine adverse event reporting system (VAERS): implications for assessment of suspected vaccine-provoked vasculitis
    Elizabeth M Begier
    Vaccine Safety Branch, Division of Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20852 1448, USA
    J Rheumatol 31:2181-8. 2004
    ..To examine polyarteritis nodosa (PAN) reports to the Vaccine Adverse Event Reporting System (VAERS) as the initial stage in investigating the hypothesis that vaccination can very rarely cause PAN...
  13. ncbi request reprint Transient bulging fontanelle after vaccination: case report and review of the vaccine adverse event reporting system
    Stephen B Freedman
    Division of Pediatric Emergency Medicine, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
    J Pediatr 147:640-4. 2005
    ..To describe the features of transient bulging fontanelle (TBF) after vaccination...
  14. doi request reprint Safety of varicella vaccine after licensure in the United States: experience from reports to the vaccine adverse event reporting system, 1995-2005
    Sandra S Chaves
    Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA
    J Infect Dis 197:S170-7. 2008
    ..Ongoing safety surveillance and further studies may shed light on some of the hypothesized associations...
  15. ncbi request reprint Unexplained sudden death, including sudden infant death syndrome (SIDS), in the first and second years of life: case definition and guidelines for collection, analysis, and presentation of immunization safety data
    Gerhard Jorch
    University of Magdeburg, Magdeburg, Germany
    Vaccine 25:5707-16. 2007
  16. ncbi request reprint Guidelines for submitting adverse event reports for publication
    William N Kelly
    William N Kelly Consulting, Inc, Oldsmar, Florida 34677, USA
    Pharmacoepidemiol Drug Saf 16:581-7. 2007
    ..They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events...
  17. ncbi request reprint Guidelines for submitting adverse event reports for publication
    William N Kelly
    William N Kelly Consulting, Inc, Oldsmar, Florida 34677, USA
    Drug Saf 30:367-73. 2007
    ..They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events...
  18. ncbi request reprint Epoetin and pure red-cell aplasia
    M M Braun
    N Engl J Med 352:511-2; author reply 511-2. 2005
  19. ncbi request reprint Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)--United States, 1991-2001
    Weigong Zhou
    Epidemic Intelligence Service Program, Epidemiology Program Office, CDC, USA
    MMWR Surveill Summ 52:1-24. 2003
    ..Therefore, postmarketing monitoring of adverse events after vaccinations is essential. The cornerstone of monitoring safety is review and analysis of spontaneously reported adverse events...