Tissue Agnostic Drug Development in Oncology

On 17 October 2022 the FDA published the draft guidance on tissue agnostic drug development in oncology for industry.

This guidance provides recommendations to sponsors regarding considerations for tissue agnostic drug development in oncology. This guidance describes the development of tissue agnostic drugs, scientific considerations in determining when tissue agnostic oncology drug development may be appropriate, and, if appropriate, issues to be addressed during such development.

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