Laws, Regulations, Guidance, and Concept Papers

FDA published several new guidance, both draft and final, this week:

  • 2 are administrative
  • 2 address quality
  • 1 addresses format for submission of vaccines data
  • Bonus excellent publication: ICH Q&A regarding Q7. It includes just under 60 questions and an appendix that links each Q&A to the section of Q7.

TGA published 2 relevant items. A fantastic collection this week of non-guidance publications:

  • An MHRA blog
  • APICs guideline for audit of starting materials
  • 2 periodic newsletters from the HPRA


Enforcement this week included:

  • Warning letters to 3 OTC manufacturers located outside the US
  • 2 warning letters to compounding pharmacies

Warning letters this week demonstrate the intense focus on OTC manufacturers that FDA began in CY2017. FDA has accelerated their focus in this calendar year with 14 of 33 drug GMP warning letters issued to OTC drug manufacturers.

This week had the usual collection of recalls and import alerts. Cantrell Drug Company entered into a consent decree agreement with the government. One report of GDP non-compliance was issued for a distribution site in the Czech Republic.