Wrap-up of a few notable news stories from last week:

  • RAPS reports that FDA Enforcement Actions have increased in 2012 based on a study originally published by Greenleaf Health, LLC.
  • While MDUFA III is in the midst of implementation, a quick reminder that establishment registration and product listing renewal has been extended to January 31, 2013, and listing of proprietary product names is not required until March 31, 2013.
  • The European Commission has released new Good Manufacturing Practices guidelines, including major revisions in four chapters. The new chapters go into effect June 17, 2013. Read more here courtesy of RAPS.

Happy Monday!

- RTK

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