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On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on the heels of FDA’s first low-risk determination for a food animal with an intentional genomic alteration. These concurrent developments are indicative of FDA’s continued assessment of gene therapy and genome editing technology and attempts to provide guidance to innovators. Moreover, they may portend a growing focus on GE technologies at the regulatory agency. To this end, Center for Biologics Evaluation and Research (CBER) Director Peter Marks is anticipated to publish an op-ed titled “Enhancing gene therapy regulatory interactions” in Expert Opinion on Biological Therapy.



FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing

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On March 14, 2022, U.S. Food and Drug Administration (FDA) issued two draft guidances: “Human Gene Therapy Products Incorporating Human Genome Editing (GE)” and a draft guidance on Chimeric Antigen Receptor (CAR) T cell product development. These draft guidance documents were issued on the heels of FDA’s first low-risk determination for a food animal with an intentional genomic alteration. These concurrent developments are indicative of FDA’s continued assessment of gene therapy and genome editing technology and attempts to provide guidance to innovators. Moreover, they may portend a growing focus on GE technologies at the regulatory agency. To this end, Center for Biologics Evaluation and Research (CBER) Director Peter Marks is anticipated to publish an op-ed titled “Enhancing gene therapy regulatory interactions” in Expert Opinion on Biological Therapy.Read the <a target="_blank" href="https://lifesciences.mofo.com/topics/fda-issues-draft-guidance-on-human-gene-therapy-products-incorporating-human-genome-editing.html">full blog post</a>.

FDA Issues Draft Guidance on Human Gene Therapy Products Incorporating Human Genome Editing