Laws, Regulations, Guidance, and Concept Papers
- This has been an unusually slow summer week
- 5 documents published by FDA — 3 of which address user fees for FY2019 re: generic drugs, devices, and food re-inspections
- 1 from EMA
- 2 each from WHO and TGA
- Non-guidance publications were issued by FDA, EMA, MHRA, ICH, and HPRA.
Enforcement:
- Very slow with 1 warning letter issued to a compounding pharmacy, that’s it for GMP drug warning letters
- No device warning letters
- Nothing from Europe this week
- A few recalls and import alerts this week