Individualized Gene Therapy: US FDA Considering Device-Like Manufacturing Approval Process
CBER Director Peter Marks said the agency could streamline development by allowing sponsors to depend on an already-approved manufacturing platform and reviewing any modifications that are proposed.
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From re-examining the FDA’s place in the broader US government to how fast and flexible it can be clearing therapies in non-emergency times, the COVID-19 EUA experience is expected to have a long-lasting impact on the agency.
Draft guidance will help sponsor-investigators working on individualized gene therapies. The focus on basic administrative and procedural aspects of interaction with the FDA leaves many policy and commercialization questions about how these personalized investigational products should be studied unanswered.
CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.