US FDA Gene Therapy Review Reorg Draws Congressional Interest

A bipartisan letter from the leaders of the House Energy and Commerce Committee’s Health Subcommittee indicates the FDA’s efforts to revamp the review structure for cell and gene therapies will be closely watched by key legislators.

gene therapy
The House Energy and Commerce Committee wants more information on CBER's new Office of Therapeutic Products. • Source: Shutterstock

The US Food and Drug Administration’s overhaul of the cell and gene therapy product review divisions will be tracked by a key congressional committee, which is expecting tangible signs of improvement in communication with sponsors.

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