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US FDA's 'Program Alignment' Inspection Scheme Coming Mid-May; Details Still Murky

 
• By Shawn M. Schmitt

The agency's new inspectional approach – which will be structured along commodity-specific product lines – will be ready for primetime on May 15, the device center's compliance chief says.

Mark your calendar: US FDA investigators will begin inspecting device manufacturing facilities using the agency's brand-new "program alignment" inspectional approach on May 15.

That's according to Robin Newman, director of the Office of Compliance within FDA's Center for Devices and Radiological Health, who says agency staff is "working very hard" to make sure...

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