Cell & gene therapy clinical trials, development promoted in three new FDA guidance documents – Trends in Cell, Tissue, and Gene Therapies

On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to clinical trial design, post-approval data collection, and FDA’s expedited approval programs. Below we summarize how the new guidance may help sponsors of CGTs and other regenerative medicine therapies, describing how the documents continue the trend of FDA promoting development of medical products to…
By: Hogan Lovells