US FDA's Slim October User Fee Calendar Brings Some Controversy

 
• By Bridget Silverman

Advisory committee concerns cast clouds over Iterum’s oral antibiotic, Intercept’s Ocaliva, and perioperative immuno-oncology regimens, while CSL and Pfizer aim to take their hematology franchises in new directions.

October calendar
Fewer FDA approvals are expected in October compared to the prior month, based on the number of user fee goals. • Source: Shutterstock

More from US FDA Performance Tracker

More from Regulatory Trackers