After The Peak Of 2018’s US FDA Approval Record, 2019 Looks Like A Valley
Executive Summary
FDA’s second half 2019 user fee calendar features almost 30 novel agents, but another record-breaking tally is out of reach.
You may also be interested in...
CDER Midyear Report: Sponsors Struggle With Drop In Novel Approval Rate
CDER has approved only 13 novel products in the first half of 2019 while issuing at least seven such CRLs during that timeframe. The sparse approval landscape more so resembles that of 2016 compared with the banner years of 2017 and 2018.
Hazards Ahead For New Drugs At US FDA Amid Safety Concerns, Shutdown Disruption
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.