Posted by Michael Wonder on 05 Nov 2022
FDA finalises umbrella trial guidance for cell and gene therapies
4 November 2022 - The US FDA laid out its recommendations for sponsors to study multiple versions of a cellular or gene therapy in a clinical trial for a single disease.
The agency said its final guidance should help sponsors conduct umbrella trials of similar products for the same disease more efficiently to bring cell and gene therapies to market sooner.
