CRLs In 2019: Steady In Number, But Biosimilar Performance Improves
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.
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The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.
CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.
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.