Laws, Regulations, Guidance, and Concept Papers:
- FDA published 3 this week including 1 on sunscreens that has been in draft form since 2011.
- EMA published 1 on IMPs for consultation.
- HPRA, WHO, Health Canada, and CDSCO each published 1.
Among the non-guidance publications this week:
- The MHRA inspectorate blog provides examples of data integrity failures in the GDP area. It includes a nice section on spreadsheets which is also applicable across all GXP areas.
- FDA and EMA also published a handful in this area.
Enforcement:
- FDA posted 3 warning letters to drug firms this week and 1 to a compounding pharmacy.
- We also have a collection of Class II and III drug recalls and a handful of import alerts.
- Europe published 1 report of GMP non-compliance.
- Pfizer entered into a corporate integrity agreement, along with their extensive monetary fine.