Understanding FDA Cell And Gene Therapy Guidance

By Rebecca Roberts, Ph.D. and Lina Jamis, M.S.

CRISPR gene therapy drugs are already revolutionizing medicine, and the clinical landscape is beginning to shift considerably. However, staying up-to-date with all the developments in the regulatory space and understanding how these developments will affect cell and gene therapy products can be a challenge.

In this blog post, learn about recent key developments in the cell and gene therapy space, particularly the publication of an important new FDA guidance that may help accelerate the development of these novel biologics. This blog also discusses the release of an internationally-recognized lexicon of gene editing terms, industry meetings from advocacy groups and the FDA, and structural changes in the FDA office that governs cell and gene therapy products.