The US Food and Drug Administration (FDA) has published its draft recommendations for managing cell and gene therapy (CGT) manufacturing changes. The new draft recommendations outline actions for sponsors of Investigational New Drug Applications (INDs) and applicants of Biologics License Applications (BLAs) for CGT products. The draft guidance covers the FDA’s thinking on the management of manufacturing changes for CGT products and compatibility studies to assess final product quality. This advice will “improve product quality, expand product supply, or improve…