The FDA's sentinel initiative-A comprehensive approach to medical product surveillance
Author:
Affiliation:
1. Center for Drug Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA
2. Center for Biologics Evaluation and Research, Food and Drug Administration; Silver Spring Maryland USA
Publisher
Wiley
Subject
Pharmacology (medical),Pharmacology
Link
http://onlinelibrary.wiley.com/wol1/doi/10.1002/cpt.320/fullpdf
Reference10 articles.
1. The new Sentinel Network - improving the evidence of medical-product safety;Platt;N. Engl. J. Med.,2009
2. Developing the Sentinel System--a national resource for evidence development;Behrman;N. Engl. J. Med.,2011
3. The Food and Drug Administration's Post-Licensure Rapid Immunization Safety Monitoring program: strengthening the federal vaccine safety enterprise;Nguyen;Pharmacoepidemiol. Drug Saf.,2012
4. Mini-Sentinel and regulatory science-big data rendered fit and functional;Psaty;N. Engl. J. Med.,2014
5. Sentinel Program Interim Assessment http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm
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