ICH S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

1 May 2023 – the FDA published the final ICH S12 guidance on nonclinical biodistribution (BD) studies for gene therapy (GT) products.

The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/ refine/ replace) principles.