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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 from Congress to deal with the growing sector....

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Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

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Keep Talking: US FDA’s Beleaguered Biologics Center Remains Vital To Regenerative Medicine

 
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EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 
• By Eliza Slawther

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.

EU Wants Industry To Define ‘Trade Secrets’ Under Health Data Sharing Regulation

 
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