US FDA To Generic Sponsors: Don't Call Us, We'll GDUFA You
Executive Summary
FDA says there are only a few situations where the ANDA status call to the project manager is necessary, and industry seems to agree that review system improvements make the once-contentious check-in process less necessary.
You may also be interested in...
Generic Drug Sponsors Seek Advance Notice Of Approvals From US FDA
Pre-launch communication from agency would allow sponsors to ramp up commercial activities and could head off some innovator company legal challenges to ANDA approvals, attorneys say; CDER’s Moscicki suggests GDUFA goal dates now provide sponsors some level of predictability.
ANDAs Can Get Priority, Eight-Month Reviews Under User Fee Deal
GDUFA II gives certain generics the possibility of an even faster review clock, which burnishes FDA's credentials in the drug pricing debate, but in order to take advantage, applications will need to be of high quality in addition to addressing a public health priority.
ANDA Communication Complaints: FDA Takes Licking, Keeps Ticking
As sponsors vent about uncertain status of their ANDAs, FDA Office of Generic Drugs indicates number of ideas are in process, including providing target action dates for applications without formal review goals.