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Individualized Gene Therapy: US FDA Considering Device-Like Manufacturing Approval Process

 
• By Derrick Gingery

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.

Genetic engineering and gene manipulation concept. Hand is replacing part of a DNA molecule. 3D rendered illustration of DNA.
The FDA is expecting to receive many more applications for individualized treatments, both in its small-molecule drug and gene therapy divisions. • Source: Shutterstock

Approvals of individualized gene therapy approvals at the US Food and Drug Administration could speed up using a 510(k)-like process under consideration.

Peter Marks, director of the Center for Biologics Evaluation and Research, said the FDA needs a workable pathway not requiring new authority

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