Laws, Regulations, Guidance, and Concept Papers:

  • Guidance documents this week were from the FDA, EMA, and HPRA.
  • Among the FDA ones are 2 programs where FDA will further pursue and investigate criteria for their Quality metrics program.
  • The non-guidance documents include publications from MHRA, EMA, FDA, TGAA, and ICH.  Several are worth a serious read.

Enforcement:

  • By and large an unusually sparse week for enforcement.
  • Warning letter enforcement was light with just 1 warning letter to an API site in China where both deficiencies focused on data integrity failures.
  • There were a few import alerts and recalls.
  • Six GDP non-compliance reports associated with sites in Romania were published.
  • Most interesting is the 32-page form 483 issued to the Mylan Pharmaceutical site in Morgantown, WV*.
    • This is a must read, I would expect additional enforcement action of some sort.

Everyone have a happy and safe July 4th holiday!