Do FDA Submission, Approval Declines Outside Cancer Signal Future Treatment Gaps?
Outlining a "fairly substantial decline in the number of non-oncology NMEs approved compared to last year" plus downward trend in applications, US FDA's Jenkins underscores continued "tremendous needs" for primary care products.
You may also be interested in...
CDER approved 23 new drugs in the first half of 2017, topping the 22 approved in all 2016; there are at least 18 products in CDER's pipeline with a user fee date this year.
Sen. Burr asks FDA whether fee revenue should be rebated for not meeting some PDUFA V goals.
The latest drug development news and highlights from our FDA Performance Tracker.