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Day 1: US FDA Launches New 'Super Office,' Says It’s Already Proven Its Worth

 
• By Shawn M. Schmitt

Speaking at MedCon 2019, CDRH Director Jeff Shuren announced 1 May is officially the first day for the agency’s new Office of Product Evaluation and Quality. The agency lists several examples of how it has already been used in a pilot setting to remove potentially harmful products from market sooner, and resulted in more efficient and safer product reviews.

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Today is officially the first day of the US Food and Drug Administration’s Office of Product Evaluation and Quality – a so-called “Super Office” that the agency hopes will make it more efficient and effective. Regulators say the new model of workflow has already identified safety signals sooner and streamlined their work.

Speaking via video at MedCon 2019 in Cincinnati, OH, Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, announced the first day of the new OPEQ,...

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Pathogen Sharing System Part Of Global Pandemic Agreement

 
• By Neena Brizmohun

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