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US FDA Eyes Project Orbis-Type Approach For Cell And Gene Therapies

 
• By Sue Sutter

A process in which the FDA coordinates reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in a given disease area, CBER’s Peter Marks tells the Biopharma Congress. The biologics center also looks to apply the philosophy underlying the Real-Time Oncology Review program.

Globe puzzle
CBER wants to take a more global view of the regulation of cell and gene therapies for very rare diseases. • Source: Shutterstock

The US Food and Drug Administration is eyeing potential adoption of a Project Orbis-type approach for cell and gene therapies to treat rare diseases.

A process where the FDA can coordinate reviews with other regulators would allow for better leveraging of global patient populations with ultra-rare diseases and attract more commercial interest in development for a particular disease area, Center for Biologics Evaluation and Research Director Peter

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