US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes

Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.

Tree branches
Some of the branches of FDA's Office of Tissues and Advanced Therapies have grown so large they are unmanageable. • Source: Alamy

The US Food and Drug Administration’s Office of Tissues and Advanced Therapies is eyeing an internal reorganization, as well as changes in how it interacts with sponsors, to help it keep up with the burgeoning workload involving cell and gene therapies.

The tremendous growth in cell and gene therapy investigational new drug applications in recent years has necessitated a rethinking in...

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