Protecting Public Health: Unique Identification of Facilities in Adverse Event Reporting
Authors
Joshua Wayne Curto, Timothy Michael DeFreitas, Vaughn Christopher Walker
Sponsor
Food and Drug Administration
Advisors
James Hanlan, David DiBiasio
Term
October – December 2013
Project Outcomes
Abstract
The purpose of this project was to provide the United States Food & Drug Administration with an evaluation of the possible use of unique facility identifiers within the drug adverse event reporting system. Through interviews, research, and database demonstrations, we identified current shortcomings in the availability of facility information and proposed a future state which would expedite investigations of public health signals. A gap analysis was then utilized to develop proposed policy, informatics, and process changes to improve FDA.