August 29th 2025
The authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
Contamination Control Strategies for Cell and Gene Therapy Facilities at INTERPHEX 2024
April 22nd 2024At INTERPHEX 2024, a panel of experts gave insight on new regulatory requirements for contamination control and provided advice for how to implement a contamination control strategy in existing facilities.
Europa Perspectives: EMA Transparency in Investigating CAR-T Secondary Cancers
February 28th 2024Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.