Laws, Regulations, Guidance, and Concept Papers

This was a short week in the US with the Memorial Day holiday on Monday:

  • The FDA published 6 guidance documents
  • WHO published 1
  • EMA didn’t publish any in the areas we monitor
  • The non-guidance collection includes the usual from the FDA, EMA, MHRA, and HPRA this week
  • Among the more important announcements are the addition of 2 EU countries to the existing MRA between FDA/EMA


  • FDA published 3 warning letters to drug firms, 2 of which are OTC manufacturers
    • This continues their heavy emphasis of the OTC market segment that started in 2017 (we will publish a special supplement on this topic in July)
  • Europe published 1 report of GDP non-compliance
  • FDA released what sounds like a very painful form 483 from their re-inspection of Zimmer-Biomet
  • FDA published drug recalls in all classes this week, more than a handful of recalls awaiting classification, and 1 import alert