A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The sponsor of the FAME II trial, which is assessing the efficacy of fractional flow reserve (FFR) as a tool to improve stenting outcomes, said it is halting enrollment after an analysis revealed a significant benefit for patients in the FFR arm. MedPage Today