FDA’s New CGT Flexibilities: What They Really Ask For, Why Training Is No Longer Optional
By Judy Carmody, Ph.D. When FDA issued its May 2026 guidance on Chemistry, Manufacturing, and Controls flexibilities for cellular and gene therapy products pursuing a BLA, early coverage focused on what sponsors won’t have to do: no minimum number of PPQ batches, permissive release criteria during early clinical phases, single-lot analytical method validation in appropriate…
