FDA Releases Final Industry Guidelines for CAR-T Cell Therapy
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FDA Releases Final Industry Guidelines for CAR-T Cell Therapy
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FDA Releases Final Industry Guidelines for CAR-T Cell Therapy
On January 29th, the FDA issued the final industry guidelines for the development and considerations of CAR-T cell therapy products. This update builds upon the draft released in March 2022, incorporating feedback and input from stakeholders to form the ultimate guidance.
The guidelines provide specific recommendations on chemistry, manufacturing, and controls, pharmacology and toxicology, as well as clinical study design and comparability studies for CAR-T cell products. (For further details, refer to previous articles on Dingxiangyuan: FDA Update: All Marketed CAR-T Therapies to Include Black Box Warning)
While the focus of this guidance is on CAR-T cell products, the FDA emphasizes that much of the information and recommendations are also applicable to other genetically modified lymphocyte products, such as CAR-NK or TCR-T. Additionally, attention is drawn to the need for ongoing monitoring of the persistence and long-term follow-up of CAR-T cells in clinical settings.
(Image and information source: FDA)
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