Keeping Track: US FDA Receives Submissions Galore As Year Ends
A roundup of new applications submitted to FDA’s Center for Drug Evaluation and Research.
You may also be interested in...
US FDA Limits GMP Exemption For ‘N of 1’ Investigational New Drugs
Agency drafts guidance on how to apply requirements for chemistry, manufacturing and controls, and for good manufacturing practices, to bespoke antisense nucleotides.
Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Oxbryta Approval Headlines Pre-Thanksgiving Week Of News
The latest drug development news and highlights from our US FDA Performance Tracker.