Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments

摘要

The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation." The purpose of the public workshop is to discuss factors FDA should consider when evaluating drugs for orphan designation that treat a tissue agnostic disease or condition in oncology, and additional factors related to orphan exclusivity FDA should consider when approving a product with a tissue agnostic indication.