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The products covered by the expanded CLAA framework include CAR-T cell therapies, gene editing and gene replacement treatments, and animal tissue-derived products such as heart valves

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The product was well-tolerated and didn't cause any severe complications

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Popular Reads The committee members who voted yes generally believed the risks to be minimal, while those who voted no tended to worry about safety risks and effectiveness, and expressed concern that adding the peptide to the compounding list would create a false impression that it has been evaluated with the same rigorous standards as an FDA-approved drug

Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria