Laws, Regulations, Guidance, and Concept Papers

A collection of both draft and final guidance:

  • The FDA and EMA published this week
  • Others also issued guidance including WHO, HPRA, Health Canada, TGA, and CDSCO.  Much to read!

Also, the non-guidance publications continue:

  • MHRA, EMA, and FDA published
  • Among this later collection are the MHRA GCP Inspection Metrics
  • Changes in the FDA IOM 2018 (regarding electronic records and cosmetics)
  • Additional item in the EMA Q&A for GMPs


Enforcement was light again this week:

  • 1 drug manufacturer receiving a warning letter
  • 2 new drug firms forms-483 released by FDA
  • Several forms-483 issued to compounding pharmacies
  • A small handful of recalls
  • 1 lone import alert for the week
  • 2 pending consent decree agreements with stem cell clinics — supporting FDA’s focus on tightly regulating this area