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FDA Launches Global Rx Quality Initiative With Plans To Rely On Non-U.S. Regulators

 
• By Sarah Karlin-Smith

Agency restructures staff as it prepares for new U.S.-EU mutual reliance activities to enhance pharmaceutical quality but offers few details on upcoming plans.

FDA rolled out a new global pharmaceutical quality initiative it says will “deepen” its reliance on other regulators announcing the creation of a new team dedicated to overseeing its mutual reliance work with the European Union.

But the agency’s May 12 announcement provided little additional insight into its plans leaving questions of how the new project...

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