Laws, Regulations, Guidance, and Concept Papers:

  • A handful of guidance documents published this week from the FDA, EMA, and ICH.
  • The usual collection of non-guidance documents also published including several slide decks from presentations made by EMA representatives.


  • 3 drug warning letters
  • A handful of recalls
  • 2 consent decree agreements
  • A few import alerts
  • Nothing this week in the enforcement area from Europe
  • One form 483 addressed poor management of complaints, including those which resulted in death