U.S. Drug Supply Chain Safety System Faces Challenges

The drug supply chain safety system faces major challenges, due particularly to globalization, speakers at a DCAT breakfast panel in New York say. “The existing U.S. supply chain safety system for F.D.A-regulated products, including drugs, is not adequate to meet the growing needs presented by globalization,” says Deborah Autor, director of the F.D.A.’s CDER Office of Compliance. While the use of foreign manufacturing facilities has increased by 185% since 2001, the number of inspections at those facilities has increased by a mere 23%, Autor...

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