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

Pharmacoepidemiol Drug Saf. 2012 Jan:21 Suppl 1:9-11. doi: 10.1002/pds.2311.

Authors

Melissa A Robb¹, Judith A Racoosin, Rachel E Sherman, Thomas P Gross, Robert Ball, Marsha E Reichman, Karen Midthun, Janet Woodcock

Affiliation

¹ Office of Medical Policy, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA. Melissa.Robb@fda.hhs.gov

PMID: 22262587
DOI: 10.1002/pds.2311

No abstract available

MeSH terms

Adverse Drug Reaction Reporting Systems
Biological Products / adverse effects
Databases, Factual*
Drug-Related Side Effects and Adverse Reactions
Equipment and Supplies / adverse effects
Humans
Pilot Projects
Product Surveillance, Postmarketing / methods*
United States
United States Food and Drug Administration*

Substances

Biological Products