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

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2017 Program & Posters

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Gutierrez-Perez, Francisco
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.