The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety-Reference-Cited by-同舟云学术

The US Food and Drug Administration's Sentinel Initiative: Expanding the horizons of medical product safety

Published:2012-01 Issue: Volume:21 Page:9-11
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Robb Melissa A.¹,Racoosin Judith A.¹,Sherman Rachel E.¹,Gross Thomas P.²,Ball Robert³,Reichman Marsha E.⁴,Midthun Karen⁵,Woodcock Janet⁶

Affiliation:

1. Office of Medical Policy, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring MD 20993 USA

2. Office of Surveillance and Biometrics, Center for Devices and Radiological Health; Food and Drug Administration; Silver Spring MD 20993 USA

3. Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research; Food and Drug Administration; Rockville MD 20852 USA

4. Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring MD 20993 USA

5. Center for Biologics Evaluation and Research; Food and Drug Administration; Rockville MD 20852 USA

6. Center for Drug Evaluation and Research; Food and Drug Administration; Silver Spring MD 20993 USA

Funder

Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2311/fullpdf

Reference5 articles.

1. Institute of Medicine The Future of Drug Safety-Promoting and Protecting the Health of the Public http://www.iom.edu/Reports/2006/The-Future-of-Drug-Safety-Promoting-and-Protecting-the-Health-of-the-Public.aspx

2. FDA The Future of Drug Safety-Promoting and Protecting the Public Health http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM171627.pdf

3. FDA 2005 Guidance for Industry Available at: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf

4. Active Surveillance for Adverse Events: The Experience of the Vaccine Safety Datalink Project;Yih;Pediatrics,2011

5. Salmon , D.A. Akhtar , A. Mergler , M.J et al H1N1 Working Group of the Federal Immunization Safety Task Force Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program 2011 127 S1 S78 S86 10.1542/peds.2010-1722 L

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