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Correlations Between Management Behaviors And Financial Indicators With Fda Compliance Leading To Medicine Shortages, Francisco Gutierrez-Perez
Correlations Between Management Behaviors And Financial Indicators With Fda Compliance Leading To Medicine Shortages, Francisco Gutierrez-Perez
2017 Program & Posters
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.