CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

…these risks will also create challenges as industry moves forward: 21st Century Cures bill. It will cost the agency money to implement and “We don’t know where the Senate will…

…these risks will also create challenges as industry moves forward: 21st Century Cures bill. It will cost the agency money to implement and “We don’t know where the Senate will…

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Robert Califf, FDA

President Obama Nominates Robert Califf as Next FDA Commissioner

By Maria Fontanazza

…to manage the Affordable Care Act, the recently passed 21st Century Cures Act, concerns in tobacco regulation, and prepares for the implementation of the largest reform of food safety laws…

…to manage the Affordable Care Act, the recently passed 21st Century Cures Act, concerns in tobacco regulation, and prepares for the implementation of the largest reform of food safety laws…

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Five Important Facts About 21st Century Cures Act

Last week the House passed the 21st Century Cures Act (H.R. 6) in 344-77 vote. The bipartisan bill, which intends to accelerate the pathway for innovative medical technologies, was introduced…

Last week the House passed the 21st Century Cures Act (H.R. 6) in 344-77 vote. The bipartisan bill, which intends to accelerate the pathway for innovative medical technologies, was introduced…

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Regulatory Innovation Should Adapt to New Health Economy

…senior industry leaders. “To meet 21st century demands for innovation, it will be important for drug and medical device manufacturers to collaborate with the FDA to consider changes to the…

…senior industry leaders. “To meet 21st century demands for innovation, it will be important for drug and medical device manufacturers to collaborate with the FDA to consider changes to the…

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