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
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