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.
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Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``Tissue Agnostic Therapies in Oncology: Regulatory Considerations for ...
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83 FR 8485
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“Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation; Public Workshop; Request for Comments,” thefederalregister.org (February 27, 2018), https://thefederalregister.org/documents/2018-03961/tissue-agnostic-therapies-in-oncology-regulatory-considerations-for-orphan-drug-designation-public-workshop-request-for-.