Trackers

Eight novel agents have user fee goal dates in November, which keeps the possibility of matching or topping the 2024 annual count alive.

October is unusually low on user fee goals for novel agents, but more than 20 applications for new indications and formulations will keep FDA staff busy, especially in oncology and ophthalmology.

The Pink Sheet breaks down the data on the 89 complete response letters recently released by the FDA, including by type of application and problems noted.