Information-Sharing Phase Dropped in Proposed Drug Review Model

November 15, 2010
The FDA has abandoned a potential modification to its current drug-review model in the face of industry concerns about the proposal. The proposed new review model would have included an “information-sharing phase” during which sponsors could meet with the FDA to discuss their application and submit amendments. The phase was dropped by the agency after industry representatives expressed hesitation about it, according to a summary of a Prescription Drug User Fee Act reauthorization meeting posted on the FDA website recently.
Washington Drug Letter