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FDA and FTC issue warnings for illegal homeopathic weight-loss remedies

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • December 20 2011

At the end of November, the Food and Drug Administration (FDA) issued warning letters to seven companies marketing diet products containing human chorionic gonadotropin (hCG

FDA issues much-anticipated draft guidance on de novo classification process

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • October 4 2011

The FDA’s draft guidance on the de novo classification process is finally available for comment purposes

Medical device user fees: FDA and industry continue to debate

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • July 21 2011

The FDA Amendments Act (FDAAA) requires that the FDA hold public meetings and conduct discussions with both the regulated industry and stakeholder groups in order to develop recommendations for the next Medical Device User Fee and Modernization Act (MDUFMA) program, which will span fiscal years 2013-17

FDA releases CDRH action plan for 510(k) and science initiatives

  • Hodgson Russ LLP
  • -
  • USA
  • -
  • January 24 2011

On January 19, 2011, the US Food and Drug Administration (FDA) released a plan for 2011 involving 25 action steps to improve the most common regulatory-approval path for medical devices, the 510(k) process