Day: January 25, 2024

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 needs to be aware of this reorganization, even though the … Read more

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 indications outside hematology and oncology. … Read more