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

Cited by 108 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Enhancing Postmarketing Surveillance of Medical Products With Large Language Models;JAMA Network Open;2024-08-16

2. Active surveillance pharmacovigilance for Clostridioides difficile infection and gastrointestinal bleeding: an analytic framework based on case-control studies;eBioMedicine;2024-05

3. Scalable Incident Detection via Natural Language Processing and Probabilistic Language Models;2023-12-01

4. The futility of adverse drug event reporting systems for monitoring known safety issues: A case study of myocardial infarction with rofecoxib and other drugs;Pharmacoepidemiology and Drug Safety;2023-10-22

5. Clinician challenges to evidence‐based prescribing for heart failure and reduced ejection fraction: A qualitative evaluation;Journal of Evaluation in Clinical Practice;2023-06-19