Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions
Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
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Novartis and Gilead longer-term data show largely steady response and survival rates, shoring up the clinical and commercial case for their products and justifying continued investment in T-cell therapies. The CAR-T pioneers discuss their progress, including with allogeneic platforms, with Scrip at ASH.
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.