Laws, Regulations, Guidance, and Concept Papers:
- Lots of PIC/S guidance this week along with a couple from the FDA and EMA and 1 each from MHRA and HPRA.
- FDA’s withdrawal of a draft biosimilar guidance is in response to industry concerns about the bar that was set in establishing biosimilarity over time. It will be interesting to see the revised draft guidance when it publishes.
- The non-guidance area had the usual collection from FDA, MHRA, EMA, TGA, HPRA, and ICH.
Enforcement:
- 1 GLP warning letter that includes an interesting reason why the warning letter recipient did not need SOPs
- 1 more OTC warning letter
- 1 issued to a compounding pharmacy
- Europe published 1 report of GMP non-compliance
- The usual collection of drug recalls
- 1 import alert in the areas we follow