Laws, Regulations, Guidance, and Concept Papers:

  • FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011.
  • EMA published 1 on IMPs for consultation.
  • HPRA, WHO, Health Canada, and CDSCO each published 1.

Among the non-guidance publications this week:

  • The MHRA inspectorate blog provides examples of data integrity failures in the GDP area. It includes a nice section on spreadsheets which is also applicable across all GXP areas.
  • FDA and EMA also published a handful in this area.


  • FDA posted 3 warning letters to drug firms this week and 1 to a compounding pharmacy.
  • We also have a collection of Class II and III drug recalls and a handful of import alerts.
  • Europe published 1 report of GMP non-compliance.
  • Pfizer entered into a corporate integrity agreement, along with their extensive monetary fine.