Checkpoint Inhibitors: US FDA Wants Consistent Adverse Event Definitions
Executive Summary
Label writing is difficult because sponsors are collecting varying adverse reaction data, agency officials say.
You may also be interested in...
US FDA Considers Mapping Generic Drug Complaints To Spot Safety Trends
A cluster of complaints in one area may inform a new safety signal or other problem, agency official says.
The Case For CAR-T Grows As Responses Hold Up Longer Term
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.