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EMA Explains When 'Out Of Specification' CAR-Ts Can Be Given To Patients

 
• By Vibha Sharma

The European Medicines Agency must be informed about each 'out of specification' batch of a cell or tissue-based advanced therapy that has been granted marketing authorization. The agency warns that if a trend is discovered, it may consider the need for regulatory actions.

3D illustration of T cells attacking a cancer cell (CAR-T cell therapy) - Illustration
Out Of Specification Issues Pose A Unique Challenge For CAR-T Therapies • Source: Shutterstock

The European Medicines Agency has issued guidance explaining how manufacturers of cell- and tissue-based therapies, such as chimeric antigen receptor T-cell (CAR-T) products, should deal with "out of specification" batches once the product is granted marketing authorization.

Production of out of specification (OOS) batches is a unique post-marketing issue faced by commercial autologous cell therapies, an

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EU Tests Unified Pathway For Combined Drug/IVD Studies

 
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The EU is testing a groundbreaking “all-in-one” process for reviewing combined drug and diagnostic trials via a single application for coordinated assessment.

EU Decision Time For Madrigal’s MASH Drug Resmetirom And 11 Others

 
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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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