BIO Comments on FDA Guidance: Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cells Products
June 10, 2022
On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes). In the comments submitted, BIO expressed appreciation for the FDA’s statement that recommendations in the guidance will be applicable to other genetically modified lymphocytes. However, as the title of the guidance is limited to (CAR) T cells and there is little mention of therapies beyond (CAR) T, BIO raised the need for additional clarity on which principles within the guidance the Agency plans to apply more broadly. To that end, BIO urged FDA to expand the scope of the guidance and provide further detail on the breadth of products the guidance would apply to, especially given the unique scientific considerations presented by certain cell types. Finally, in addition to a number of specific line edits, BIO highlighted that the landscape of regenerative medicines is continually expanding and evolving and there are a number of topics where sponsors could benefit from the issuance of additional guidances.
On Tuesday, January 3rd, BIO submitted comments in response to the Food and Drug Administration’s (FDA) recent draft guidance containing recommendations for sponsors on monitoring growth and evaluating pubertal development in clinical trials which…
BIO and its members appreciate the opportunity to work with FDA to develop and align on approaches that are robust, practical, and expedite patient focused drug development. To further enhance the Guidance, we believe that a few areas would benefit…
On Wednesday, June 22nd, BIO submitted comments on the FDA’s Quality Metrics (QM) Reporting Program. In the comments submitted, BIO stated appreciation for FDA’s intent to support a general shift toward a risk-based approach to regulation by…
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On Friday, June 10th, BIO submitted comments in response to the FDA’s draft guidance on Chimeric antigen receptor (CAR) T cell products (i.e., human gene therapy products in which the T cell specificity is genetically modified to enable recognition of a desired target antigen for therapeutic purposes). In the comments submitted, BIO expressed appreciation for the FDA’s statement that recommendations in the guidance will be applicable to other genetically modified lymphocytes. However, as the title of the guidance is limited to (CAR) T cells and there is little mention of therapies beyond (CAR) T, BIO raised the need for additional clarity on which principles within the guidance the Agency plans to apply more broadly. To that end, BIO urged FDA to expand the scope of the guidance and provide further detail on the breadth of products the guidance would apply to, especially given the unique scientific considerations presented by certain cell types. Finally, in addition to a number of specific line edits, BIO highlighted that the landscape of regenerative medicines is continually expanding and evolving and there are a number of topics where sponsors could benefit from the issuance of additional guidances.