Laws, Regulations, Guidance, and Concept Papers

We have another slow week in the publication of guidance:

  • FDA published 2 addressing post approval safety reporting for combination products and 1 regarding drug compounding
  • EMA published 1 item addressing pharmacogenomic practices
  • CDSCO (India) and TGA each published 1

We see the usual collection of non-guidance items from MHRA, EMA, FDA, and HPRA this week. This includes 2 ‘work plan’ items from the EMA.


This week of interest are:

  • 1 device warning letter
  • 3 warning letters to drug manufacturers

Each of the 3 drug warning letters includes a list of additional information that the firm is to provide to FDA in response to the letter. We also see Class I, II, and III drug recalls this week. In the device area, it seems that the falsely low results in in-vitro testing for blood levels of lead has been resolved. The culprit is a component in some rubber stoppers in BD Vacutainers® that are now the subject of a Class I recall.