Pharmaceutical industry and regenerative therapy groups want the US Food and Drug Administration (FDA) to take a more nuanced approach in guidance on reporting manufacturing changes for cell and gene therapy (CGT) products. They called on the agency to better differentiate between the types of CGT products, their stages of development and the level of risk these changes pose.
The comments were submitted in response to FDA’s draft guidance on manufacturing changes for cell and gene therapy products (RELATED: FDA issues draft guidance on reporting manufacturing changes for gene therapies, Regulatory Focus 17 July 2023)…
