Laws, Regulations, Guidance, and Concept Papers

A bit of a busier week than last week for guidance:

  • The FDA published 6 documents.
  • Nothing from EMA in the areas we follow.
  • WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance.

Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA.


Enforcement is still a bit light:

  • 1 warning letter to a drug firm
  • 1 to a compounding pharmacy