Correlations Between Management Behaviors and Financial Indicators with FDA Compliance Leading to Medicine Shortages

Citation data:

2017 Program & Posters

Publication Year:
2017
Usage 22
Downloads 13
Abstract Views 9
Repository URL:
https://scholarworks.waldenu.edu/current/17; https://scholarworks.waldenu.edu/cgi/viewcontent.cgi?article=1012&context=current
Author(s):
Gutierrez-Perez, Francisco
Publisher(s):
ScholarWorks
Tags:
Research Symposium; Business; Business Administration, Management, and Operations; Medicine and Health Sciences
article description
A series of Food and Drug Administration (FDA) interventions and enforcement actions against pharmaceutical manufacturers in the past 5-6 years led to medicine shortages in the United States.• The manufacturing shortfalls made essential medicines unavailable for the treatment of patients.• Manufacturing shortfalls implied that quality management and manufacturing systems were not empowered or adequately staffed to support the critical functions of the pharmaceutical firms.