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FDA finalizes rule on Unique Device Identification System
  • McGuireWoods LLP
  • 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


Bicameral, bipartisan compounding pharmacy legislation finally announced
  • McGuireWoods LLP
  • 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


FDA issues much-anticipated new guidance on wireless medical devices
  • McGuireWoods LLP
  • 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


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


FDA drug import rules up for public comment
  • McGuireWoods LLP
  • 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


GAO recommends Congress clarify FDA’s authority to oversee drug compounding
  • McGuireWoods LLP
  • USA
  • August 8 2013

On July 31, the Government Accountability Office (GAO) released a report updating its 2003 testimony regarding drug compounding. The report was


New FDA guidance on medical devices: enhanced reporting requirements for adverse events
  • McGuireWoods LLP
  • USA
  • August 1 2013

FDA's new Draft Guidance reviews manufacturer reporting requirements, written policies and procedures, recordkeeping and public disclosure of MDRs


Compounding animal drugs from bulk ingredients: not prohibited by Federal Food Drug and Cosmetic Act, affirmed as recently as 2011
  • McGuireWoods LLP
  • USA
  • June 28 2013

The Federal Food Drug & Cosmetic Act (FD&CA) gives FDA broad, wide and far-reaching regulatory powers. Prohibiting the compounding of medicines from


Medical device industry concerned over proposed overseas clinical trial rule
  • McGuireWoods LLP
  • USA
  • June 18 2013

FDA recently released a Proposed Rule requiring that clinical studies conducted outside the U.S. be conducted in accordance with good clinical


New FDA guidance on appeals processes for medical device denials
  • McGuireWoods LLP
  • USA
  • May 21 2013

On May 17, 2013, FDA's Center for Devices and Radiological Health (CDRH) published new guidance on maneuvering through the medical device appeals