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

Pharmacoepidemiology and Drug Safety

Volumn 21, Issue SUPPL. 1, 2012, Pages 9-11

  Robb, Melissa A ^a   Racoosin, Judith A ^a   Sherman, Rachel E ^a   Gross, Thomas P ^b   Ball, Robert ^c   Reichman, Marsha E ^a   Midthun, Karen ^c   Woodcock, Janet ^a  

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

^b CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

^c CENTER FOR BIOLOGICS EVALUATION AND RESEARCH   (United States)

Author keywords

Active surveillance; Common data model; FDA; Medical product safety; Patient privacy; Sentinel System

Indexed keywords

ADVERSE OUTCOME; ARTICLE; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HUMAN; MEDICAL INFORMATION SYSTEM; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PRODUCT SAFETY; UNITED STATES; VOLUNTARY REPORTING;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BIOLOGICAL AGENTS; DATABASES, FACTUAL; EQUIPMENT AND SUPPLIES; HUMANS; PHARMACEUTICAL PREPARATIONS; PILOT PROJECTS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84856034278     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.2311     Document Type: Article

References (5)

1. Institute of Medicine. The Future of Drug Safety-Promoting and Protecting the Health of the Public, 22 September 2006. Available at:
2. FDA. The Future of Drug Safety-Promoting and Protecting the Public Health, FDA's Response to the Institute of Medicine's 2006 Report, January 2007. Available at:
3. FDA. 2005. Guidance for Industry. Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment. FDA CDER/CBER; March 2005. (Accessed 13 January 2011).
4. Yih, W.K., Kulldorff, M., Fireman, B.H., et al. Active Surveillance for Adverse Events: The Experience of the Vaccine Safety Datalink Project. Pediatrics 2011; 127(S1): S54-S64; published ahead of print April 18, 2011. doi:10.1542/peds.2010-1722I
5. Salmon, D.A., Akhtar, A., Mergler, M.J. et al., and the H1N1 Working Group of the Federal Immunization Safety Task Force. Immunization-Safety Monitoring Systems for the 2009 H1N1 Monovalent Influenza Vaccination Program. Pediatrics 2011; 127(S1): S78-S86; doi:10.1542/peds.2010-1722L