FDA planning guidance on designations for tissue agnostic therapies

FDA is developing new guidance on tissue agnostic drug development, FDA Commissioner Scott Gottlieb said in prepared remarks on Wednesday. The guidance will focus on Orphan Drug designations based on disease molecular subtype.

Speaking at a public workshop on tissue agnostic therapies, Gottlieb also pushed for basket trials based on biomarker type, which he said will be "more efficient, faster and cheaper."...