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May 9, 2018 9:00 am - May 9, 2018 5:00 pm

Workshop: Tissue Agnostic Therapies in Oncology — Regulatory Considerations for Orphan Drug Designation

  • Government
  • Agency
  • Genetics/Genomics

The Food and Drug Administration (FDA) announces a 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.

The presentations and discussions will focus on several related topics. Topics will involve discussion of and seek input on 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 to consider when approving a product with a tissue agnostic indication. 

Members of the public may attend in person or via webcast. More information is available at this Federal Register notice.