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ISPE Named as a Source in FDA Strategic Plan for Preventing and Mitigating Drug Shortages
Date:10/31/2013

TAMPA, Fla., Oct. 31, 2013 /PRNewswire-USNewswire/ -- ISPE's report on its 2013 Drug Shortages Survey was cited twice in the Strategic Plan for Preventing and Mitigating Drug Shortages released today by the US Food and Drug Administration (FDA). The plan also formalized the FDA's commitment to engaging with ISPE "to analyze data from a recent global survey ISPE conducted on the technical, scientific, manufacturing, quality, and compliance issues that have resulted in drug shortages."  Dr. Douglas Throckmorton, deputy director of the FDA's Center for Drug Evaluation and Research (CDER), said later on a teleconference with stakeholders, "We are looking forward to continuing to work with ISPE."

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Published in June 2013, the report on ISPE's Drug Shortages Survey is available at www.ISPE.org/Drug-Shortages/2013JuneReport. The comprehensive global survey revealed no single technical or manufacturing cause for drug shortages. Instead, initial data analysis showed:

  • Issues within the quality systems of manufacturing can lead to drug shortages.
  • Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages. 
  • Improved regulatory interaction can mitigate the likelihood of a shortage.

"We are pleased that ISPE's work has been helpful to the FDA in its consideration of the challenges of addressing drug shortages," says Nancy S. Berg, President and CEO of ISPE. "The survey reveal
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