Newsletter - January 25, 2024
What Does The Box Warning on Approved CAR-Ts Mean for New CAR-Ts?
About 2 months after the first public reports of T-cell cancers linked to CAR-T therapies, the FDA finally decided to put a Box warning on all approved CAR-T therapies for unexpected malignancies. At the same time, the FDA also raised new expectations from CAR-T therapies in development, particularly those for...Read More
What Does FDA Reorganized Audit Office Means to You?
The FDA announced a major reorganization of its Office of Regulatory Affairs (ORA) which currently leads all FDA audits, litigations, and enforcement actions to reorganize its staff involved with food facility inspections from those involved in drug, biologic, and medical device inspections. The regulated industry...Read More
What Does The Box Warning on Approved CAR-Ts Mean for New CAR-Ts?
About 2 months after the first public reports of T-cell cancers linked to CAR-T therapies, the FDA finally decided to put a Box warning on all approved CAR-T therapies for unexpected malignancies. At the same time, the FDA also raised new expectations from CAR-T therapies in development, particularly those for...Read More
What Does FDA Reorganized Audit Office Means to You?
The FDA announced a major reorganization of its Office of Regulatory Affairs (ORA) which currently leads all FDA audits, litigations, and enforcement actions to reorganize its staff involved with food facility inspections from those involved in drug, biologic, and medical device inspections. The regulated industry...Read More
