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FDA finalizes rule on Unique Device Identification System

USA - October 9 2013 On Sept. 24, 2013, U.S. Food and Drug Administration (FDA) issued its final rule on its Unique Device Identification System (UDI) after months of...

John C. Saran.

Bicameral, bipartisan compounding pharmacy legislation finally announced

USA - October 7 2013 On Sept. 25, 2013, a bipartisan group of House and Senate members reached agreement on legislation (the "Compounding Quality Act") to help ensure the...

Mary C. DeBartolo.

FDA issues much-anticipated new guidance on wireless medical devices

USA - August 20 2013 The medical device industry has gone wireless as a GAO report from August 2012 and an episode of Homeland demonstrated last year and...

Mary C. DeBartolo.

FDA: New user fees begin Oct. 1, 2013, increases up to 10

USA - August 13 2013 On Aug. 2, 2013, the FDA published its fiscal year 2014 user fee schedules in the Federal Register. The new user fees will be in effect Oct. 1, 2013...

Mary C. DeBartolo.

FDA drug import rules up for public comment

USA - August 9 2013 In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). Title VII of the FDASIA provides the FDA with new...

Mary C. DeBartolo.