The Food and Drug Administration (FDA) released draft guidance titled “Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing” (draft guidance; Federal Register notice). What is it. The guidance is intended to help sponsors developing human gene therapy products that incorporate in vivo and ex vivo genome editing of human somatic cells make greater use… (Colocho, June 3, 2026) #Food and Drug Administration, #Prescription Drugs