The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise-Reference-Cited by-同舟云学术

The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise

Published:2012-01 Issue: Volume:21 Page:291-297
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Nguyen Michael¹,Ball Robert¹,Midthun Karen¹,Lieu Tracy A.²³

Affiliation:

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

2. Department of Population Medicine; Harvard Pilgrim Health Care Institute and Harvard Medical School; Boston MA 02215 USA

3. Division of General Pediatrics; Children's Hospital Boston; Boston MA 02115 USA

Funder

Food and Drug Administration (FDA) through Department of Health and Human Services

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.2323/fullpdf

Reference31 articles.

1. National Vaccine Program Office Draft Strategic National Vaccine Plan 2008 http://www.hhs.gov/nvpo/vacc_plan/index.htm

2. Federal Immunization Safety Task Force Federal Plans to Monitor Immunization Safety for the Pandemic 2009 H1N1 Influenza Vaccination Program 2009 http://www.flu.gov/professional/federal/fed-plan-to-mon-h1n1-imm-safety.pdf

3. Salmon D Yih WK Lee G et al Development of national systems for monitoring the safety of medical products: lessons from a new vaccine safety surveillance system

4. Food and Drug Administration regulation and evaluation of vaccines;Marshall;Pediatrics,2011

5. Approaches to evaluating safety of vaccines through the life cycle at the Food and Drug Administration;Ball;Pediatrics,2011

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