Laws, Regulations, Guidance, and Concept Papers
- Another collection of FDA User Fee Rates for FY2019 was released (including those for drugs, outsourcing facilities, and biosimilars).
- EMA published several items including a broad draft guideline that covers gene therapy products and the CAR-T family of products.
- WHO published 3 guidance for consultation.
- HPRA, Health Canada, and PIC/S each published 1 item.
To see the complete list of laws, regulations, guidance, and concept papers published this week, start your FREE GMP Regulatory Intelligence Trial today.
- Picked up this week with 5 warning letters:
- 1 device
- 1 compounding pharmacy
- 3 pharma firms
- We continue to provide the FDA requested information in our summaries (free consulting for anyone who has similar problems).
- Several import alerts were put in place for failure to follow drug GMPs, including for one of Hospira’s sites in India with exceptions for ‘necessary’ medicines.
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