The FDAs sentinel initiative A comprehensive approach to medical product surveillance

Clinical Pharmacology and Therapeutics

Volumn 99, Issue 3, 2016, Pages 265-268

  Ball, R ^a   Robb, M ^a   Anderson, S A ^a   Dal Pan, G ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DABIGATRAN; INFLUENZA VACCINE; OLMESARTAN; ROTAVIRUS VACCINE;

CLINICAL ASSESSMENT; DRUG SAFETY; DRUG SCREENING; DRUG SURVEILLANCE PROGRAM; ELECTRONIC MEDICAL RECORD; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE SYSTEM; HEALTH SURVEY; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT; PATIENT CARE; PRIORITY JOURNAL; PUBLIC HEALTH; REVIEW; SENTINEL SYSTEM; ADVERSE EFFECTS; DEVICES; LEGISLATION AND JURISPRUDENCE; POSTMARKETING SURVEILLANCE; STANDARDS; UNITED STATES;

ADVERSE DRUG REACTION REPORTING SYSTEMS; EQUIPMENT AND SUPPLIES; HUMANS; PHARMACOVIGILANCE; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84958877160     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1002/cpt.320     Document Type: Review

References (10)

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2. Behrman R.E., Benner J.S., Brown J.S., McClellan M., Woodcock J., & Platt R. Developing the Sentinel System-a national resource for evidence development. N. Engl. J. Med. 364, 498-499 (2011
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5. Sentinel Program Interim Assessment www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm272170.htm
6. Mini-Sentinel collaborators. http://www. mini-sentinel.org/about-us/collaborators. aspx
7. FDA Sentinel study finds no association between venous thromboembolism, and Gardasil vaccination. http://www.fda. gov/BiologicsBloodVaccines/Guidance Compliance RegulatoryInformation/Post-MarketActivities/ucm442585.htm
8. Health Policy Brief: The FDAs Sentinel Initiative, Health Affairs, June 4, 2015
9. Moore T.J., & Furberg C.D. Electronic health data for postmarket surveillance: a vision not realized. Drug Safety Vol. 38, pp 601-610 (Springer International Publishing, New York, NY, 2015
10. Pilot of self-controlled tree-temporal scan analysis for Gardasil vaccine version 2.0 http://mini-sentinel.org/methods/methods-development/details.aspx?ID51058