CDRH Eyeing Drug Money, “True Dialogue” in User Fee Talks

article image

FDA device officials appear to be eyeing the big dollars tied to drug user fee programs with some envy, and other updates from the MDUFA V negotiations.

The device industry’s goal to keep FDA user fees close to current levels in the next round of the program (MDUFA V) is hitting a snag in early negotiation meetings with agency officials who are raising FDA drug user fees as a comparator.


This article is restricted to subscribers only.

Sign in to continue reading.


We're here to help! Please contact us at: