Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases
Generic and brand firms both seem to want ‘very black and white lines’ on orphan exclusivity, but FDA isn't so sure how to distinguish biomarker-targeted disease from histologically-defined disease.
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Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
Reorganization also may force change to commissioner succession plan.
Ilan Irony will take over as acting director of the Office of Orphan Products Development later this month.