Laws, Regulations, Guidance, and Concept Papers

It’s a very light week for new guidance documents, but do note that the FDA has two in the area of tobacco. The non-guidance publications include the usual collection from FDA, EMA, MHRA, HPRA, and TGA. The FDA also released the form 483 for a recent publication of Biocon’s facility in Malaysia.


Enforcement includes:

  • 2 device warning letters
  • 1 warning letter to a contract laboratory in France
  • 1 to a compounding pharmacy

We see the usual collection of recalls and just a few import alerts. Nothing from the Europeans published this week.