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FDA’s International Harmonization Plan Points To Ongoing Priorities

 
• By Elizabeth Orr

A new draft global harmonization plan from the device center at the US Food and Drug Administration may not contain any surprises, but it does highlight increasing agency engagement with international bodies.

Business people hold pieces of a puzzle to symbolize unity.
• Source: Shutterstock

The new International Harmonization Draft Strategic Plan from the US Food and Drug Administration shows that the agency may take more action on single-audit programs and increase its interaction with previously neglected regions like Asia and South America, an expert who reviewed the document for Medtech Insight said.

Kim Trautman, who helped set international policy for the Center for Devices and Radiological Health during her 24 years at the FDA, noted that the plan “is really a summary...

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