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Reimagining The 'Case For Quality': FDA Looking At More Hands-Off Approach, CDRH Director Shuren Says

 
• By Shawn M. Schmitt

In an effort to step back some from its role as a ringleader for the Case for Quality initiative, US FDA wants to create a "collaborative community" so various industry stakeholders can have a say in the six-year-old scheme that aims to drive a quality mindset throughout device manufacturing organizations.

US FDA is looking to form a "collaborative community" to help it step back a bit from its role as a ringleader for the Case for Quality initiative it created six years ago, the head of the agency's device center says.

Center for Devices and Radiological Health Director Jeffrey Shuren claims that by taking a more hands-off approach, FDA would help strengthen the Case for Quality. The scheme –...

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