Laws, Regulations, Guidance, and Concept Papers
A bit of a busier week than last week for guidance:
- The FDA published 6 documents.
- Nothing from EMA in the areas we follow.
- WHO, CDSCO, Health Canada, TGA, and HPRA also published guidance.
Non-guidance publications from the usual sources MHRA, EMA, FDA. Also of interest is 1 each from TGA and PMDA.
Enforcement
Enforcement is still a bit light:
- 1 warning letter to a drug firm
- 1 to a compounding pharmacy