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Mobile Apps › Food and Drug Administration Safety and Innovation Act

K&L Gates LLP

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

K&L Gates LLP on

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

Fenwick & West Life Sciences Group

FDA to Finalize Mobile Medical App Rules Following Bill Passage

Fenwick & West Life Sciences Group on

Yesterday, the Senate approved the Food and Drug Administration Safety and Innovation Act (FDASIA) which provides reauthorization for major components of the Prescription Drug User Fee Act (PDUFA) set to expire at the end of...more

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